Company · US
Depuy Orthopaedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
210510(k) clearances (2 in 12 months)
740recalls (0 in 12 months)
488recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NJL | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | 251 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 125 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 118 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 100 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 56 |
| HRS | Plate, Fixation, Bone | 32 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 32 |
| LXH | Orthopedic Manual Surgical Instrument | 23 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 20 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 18 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 17 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 16 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 14 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 14 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 10 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 9 |
| LOD | Bone Cement | 9 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 6 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 5 |
| JDK | Prosthesis, Hip, Cement Restrictor | 5 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 4, 2026 | K262130 | ATTUNE Revision Knee System Depuy Orthopaedics, Inc. | JWH |
| May 22, 2026 | K252887 | DePuy ATTUNE Knee System DePuy Orthopaedics, Inc. | OIY |
| Aug 22, 2023 | K231503 | CUPTIMIZE Advanced DePuy Orthopaedics, Inc. | LLZ |
| Jan 6, 2022 | K213839 | DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. | LZO |
| Feb 19, 2021 | K210167 | DELTA XTEND Reverse Shoulder System DePuy Orthopaedics, Inc. | PHX |
| Nov 19, 2020 | K203167 | DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. | LZO |
| Oct 21, 2020 | K202472 | ACTIS Duofix Hip Prosthesis DePuy Orthopaedics, Inc. | LPH |
| Jun 18, 2020 | K201347 | DePuy ATTUNE Total Knee System DePuy Orthopaedics, Inc. | OIY |
| Jun 16, 2020 | K193540 | TRUMATCH Personalized Solutions DePuy Orthopaedics, Inc. | JWH |
| Feb 4, 2020 | K193398 | Summit DuoFix HA Coating DePuy Orthopaedics, Inc. | MEH |
| Nov 26, 2019 | K192946 | DePuy Corail AMT Hip Prosthesis DePuy Orthopaedics, Inc. | LZO |
| Nov 26, 2019 | K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis DePuy Orthopaedics, Inc. | LPH |
| Nov 8, 2019 | K182301 | PFC SIGMA Knee System DePuy Orthopaedics, Inc. | JWH |
| Apr 26, 2018 | K170339 | Summit Hip System DePuy Orthopaedics, Inc. | LZO |
| Sep 25, 2015 | K150862 | DePuy Actis Duofox Hip Prosthesis DePuy Orthopaedics, Inc. | MEH |
| Mar 10, 2014 | K132959 | DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc. | LPH |
| Apr 30, 2013 | K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS Depuy Orthopaedics | LPH |
| Mar 1, 2013 | K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS Depuy Orthopaedics | LZO |
| Oct 31, 2012 | K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS DePuy Orthopaedics, Inc. | HSN |
| Mar 12, 2012 | K111663 | TRAUMA INTERNAL FIXATION SYSTEMS DePuy Orthopaedics, Inc. | HRS |
| Dec 15, 2011 | K112218 | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS DePuy Orthopaedics, Inc. | KTT |
| Aug 30, 2011 | K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM DePuy Orthopaedics, Inc. | OIY |
| Aug 16, 2011 | K110397 | TRUMATCH PERSONALIZED SOLUTIONS DePuy Orthopaedics, Inc. | JWH |
| Jul 12, 2011 | K111077 | ORTHOSORB RESORBABLE PINS DePuy Orthopaedics, Inc. | OVZ |
| Jun 22, 2011 | K111444 | UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION DePuy Orthopaedics, Inc. | HSB |
| Mar 15, 2011 | K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM DePuy Orthopaedics, Inc. | OIY |
| Mar 10, 2011 | K093736 | DEPUY CORAIL HIP SYSTEM, REVISION STEM DePuy Orthopaedics, Inc. | LZO |
| Feb 17, 2011 | K103001 | ROCKWOOD CLAVICLE PINS DePuy Orthopaedics, Inc. | JDW |
| Dec 16, 2010 | K103408 | POSTERIOR LATERAL PLATES DePuy Orthopaedics, Inc. | HRS |
| Dec 10, 2010 | K101433 | DEPUY ATTUNE KNEE SYSTEM DePuy Orthopaedics, Inc. | OIY |
| Oct 29, 2010 | K102423 | DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc. | LPH |
| Sep 29, 2010 | K100391 | DEPUY UNIVERSAL GRIPTION TF CONES DePuy Orthopaedics, Inc. | JWH |
| Jul 23, 2010 | K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 DePuy Orthopaedics, Inc. | HRS |
| Jun 15, 2010 | K101421 | MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 DePuy Orthopaedics, Inc. | HRS |
| May 11, 2010 | K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM DePuy Orthopaedics, Inc. | HSB |
| Feb 2, 2010 | K093474 | DEPUY FRACTURE AND FUSION PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Dec 17, 2009 | K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS DePuy Orthopaedics, Inc. | JDI |
| Aug 12, 2009 | K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 DePuy Orthopaedics, Inc. | KRO |
| Jul 27, 2009 | K092122 | GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID DePuy Orthopaedics, Inc. | KWS |
| Jul 24, 2009 | K091294 | LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, DePuy Orthopaedics, Inc. | HRS |
| Jul 14, 2009 | K091751 | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP DePuy Orthopaedics, Inc. | KWS |
| Jun 26, 2009 | K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS DePuy Orthopaedics, Inc. | HRS |
| Jun 12, 2009 | K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS DePuy Orthopaedics, Inc. | JDI |
| Mar 31, 2009 | K090492 | 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS DePuy Orthopaedics, Inc. | HRS |
| Mar 23, 2009 | K083789 | ACE FISCHER EXTERNAL FIXATION SYSTEM DePuy Orthopaedics, Inc. | KTT |
| Mar 20, 2009 | K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Mar 11, 2009 | K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S DePuy Orthopaedics, Inc. | LXT |
| Mar 6, 2009 | K083642 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DePuy Orthopaedics, Inc. | KWA |
| Feb 18, 2009 | K082300 | ANATOMIC LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc. | HRS |
| Feb 9, 2009 | K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER DePuy Orthopaedics, Inc. | KYJ |
Newest 50 of 210.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | DePuy Orthopaedics, Inc. ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System. Open, Classified |
MBH | K202194 K213781 +1 |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507 Open, Classified |
OIY | K111433 |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312 Open, Classified |
KRO | K191779 |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226 Open, Classified |
KRO | K191779 |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212 Open, Classified |
KRO | K191779 |
| Mar 17, 2023 | DePuy Orthopaedics, Inc. Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 Open, Classified |
KRO | K191779 |
| Jun 29, 2022 | DePuy Orthopaedics, Inc. ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant
Part Number: 254400525 Open, Classified |
HWT | None listed |
| May 18, 2022 | DePuy Orthopaedics, Inc. MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348 Open, Classified |
LZY | K903084 |
| Mar 11, 2022 | DePuy Orthopaedics, Inc. VELYS Robotic-Assisted Solution Base
Product No.: 451570100 Terminated |
OLO | K202769 |
| Jan 5, 2022 | DePuy Orthopaedics, Inc. ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries
Product Number: 154706001 Terminated |
JWH | K160700 |
| Jan 5, 2022 | DePuy Orthopaedics, Inc. ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries
Product Number: 154909003 Terminated |
JWH | K160700 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 16
Product Code: 110016100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 14
Product Code: 110014100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 12
Product Code: 110012100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE REV STEM SZ 10
Product Code: 110010600 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 10
Part Number: 110010100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE REV STEM SZ 8
Part Number: 110008600 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 8
Part Number: 110008100 Terminated |
PHX | K101996 K170748 |
| Dec 7, 2021 | DePuy Orthopaedics, Inc. GLOBAL UNITE STD STEM SZ 6
Part Number: 11000610 Terminated |
PHX | K101996 K170748 |
| Sep 9, 2021 | DePuy Orthopaedics, Inc. ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement
Part Code:152307001 Terminated |
JWH | None listed |
| Aug 10, 2021 | DePuy Orthopaedics, Inc. TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in Terminated |
NJL | None listed |
| Aug 10, 2021 | DePuy Orthopaedics, Inc. TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in Terminated |
NJL | None listed |
| Aug 10, 2021 | DePuy Orthopaedics, Inc. TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in Terminated |
NJL | None listed |
| Aug 10, 2021 | DePuy Orthopaedics, Inc. TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component Terminated |
NJL | None listed |
| Aug 10, 2021 | DePuy Orthopaedics, Inc. TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in Terminated |
NJL | None listed |
| Aug 10, 2021 | DePuy Orthopaedics, Inc. TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component in Terminated |
NJL | None listed |
| Aug 10, 2021 | DePuy Orthopaedics, Inc. TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component i Terminated |
NJL | None listed |
| Jul 1, 2021 | DePuy Orthopaedics, Inc. ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty
Part Number: 1512-16-080 Terminated |
JWH | K160700 |
| May 7, 2021 | DePuy Orthopaedics, Inc. DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis.
Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR Terminated |
JDI | K843909 |
| Feb 22, 2021 | DePuy Orthopaedics, Inc. The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint. Terminated |
NJL | None listed |
| Feb 22, 2021 | DePuy Orthopaedics, Inc. The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee Terminated |
NJL | None listed |
| Feb 22, 2021 | DePuy Orthopaedics, Inc. ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral c Terminated |
JWH | K170806 |
| Jan 8, 2021 | DePuy Orthopaedics, Inc. Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. Terminated |
JWH | K063633 |
| Dec 15, 2020 | DePuy Orthopaedics, Inc. Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 12 Terminated |
KWA | None listed |
| Feb 13, 2020 | DePuy Orthopaedics, Inc. SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115.
The product is a femoral cutting block. Terminated |
HTZ | K043223 |
| Sep 21, 2018 | DePuy Orthopaedics, Inc. CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433
Product Usage:
The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty. Terminated |
LXH | None listed |
| Sep 21, 2018 | DePuy Orthopaedics, Inc. CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432
Product Usage:
The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty. Terminated |
LXH | None listed |
| Sep 21, 2018 | DePuy Orthopaedics, Inc. CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431
Product Usage:
The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty. Terminated |
LXH | None listed |
| Jul 18, 2018 | DePuy Orthopaedics, Inc. P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 Terminated |
JWH | K952830 |
| Jun 21, 2018 | DePuy Orthopaedics, Inc. CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511 Terminated |
KWL | K042992 K123991 |
| Apr 30, 2018 | DePuy Orthopaedics, Inc. ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee Terminated |
JWH | K160700 |
| Apr 30, 2018 | DePuy Orthopaedics, Inc. ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee Terminated |
JWH | K160700 |
| Mar 20, 2018 | DePuy Orthopaedics, Inc. (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; Terminated |
HRY | K061648 |
| Feb 27, 2018 | DePuy Orthopaedics, Inc. The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total shoulder or hemi-shoulder replacement procedures, Product labeling: LEO-1100-30-000 REV D.pdf.pdf, LEO-1100-40-0 Terminated |
KWS | K133834 |
| Feb 12, 2018 | DePuy Orthopaedics, Inc. CORAIL HIGH OFFSET STEM Collarless SIZE 14 Terminated |
KWL | None listed |
| Feb 12, 2018 | DePuy Orthopaedics, Inc. CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 Terminated |
KWL | None listed |
| Aug 31, 2017 | DePuy Orthopaedics, Inc. DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotato Terminated |
KWS | K120174 |
| Aug 31, 2017 | DePuy Orthopaedics, Inc. DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional ro Terminated |
HSD | K120174 |
| Jul 26, 2017 | DePuy Orthopaedics, Inc. Concorde Lift Torque Limiting Handle.
Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. Terminated |
LXH | None listed |
| Jul 26, 2017 | DePuy Orthopaedics, Inc. Concorde Lift Driver Shaft AO.
Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine. Terminated |
MAX | K171425 |
Newest 50 of 740.