Panels › Orthopedic
Orthopedic devices
242 product codes reviewed by the Orthopedic panel. 17,131 510(k) clearances and 7,853 recalls in the FDA data, 79% of those recalls name a 510(k).
429510(k)s in 12 months
191recalls in 12 months
6,171recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 984 | 6 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 690 | 19 |
| LXH | Orthopedic Manual Surgical Instrument | 526 | 8 |
| HWC | Screw, Fixation, Bone | 389 | 7 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 299 | 3 |
| HRS | Plate, Fixation, Bone | 288 | 20 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 255 | 0 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 214 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 213 | 1 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 203 | 0 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 197 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 182 | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 177 | 0 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 153 | 4 |
| HRX | Arthroscope | 126 | 0 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | 2 | 62 | 20 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 20 | 19 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 33 | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 2 | 32 | 0 |
| HWC | Screw, Fixation, Bone | 2 | 23 | 7 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 2 | 28 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 2 | 18 | 11 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 24 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 20 | 5 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 14 | 6 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 9 | 11 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 15 | 0 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 11 | 3 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 5 | 9 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 9 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 11 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | 9 | 2 |
| HRX | Arthroscope | 2 | 10 | 0 |
| MQV | Filler, Bone Void, Calcium Compound | 2 | 5 | 5 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 9 | 0 |
| OUR | Sacroiliac Joint Fixation | 2 | 7 | 2 |
| LXH | Orthopedic Manual Surgical Instrument | 1 | 0 | 8 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 3 | 4 |
| LOD | Bone Cement | 2 | 1 | 6 |
| NKG | Posterior Cervical Screw System | 2 | 5 | 0 |
| QHE | Shoulder Arthroplasty Implantation System | 2 | 4 | 1 |
| HTY | Pin, Fixation, Smooth | 2 | 3 | 1 |
| JDR | Staple, Fixation, Bone | 2 | 2 | 2 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 2 | 3 | 1 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 3 | 0 |
| HTN | Washer, Bolt Nut | 2 | 3 | 0 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 3 | 0 |
| JDZ | Mixer, Cement, For Clinical Use | 1 | 0 | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 3 | 0 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 2 | 3 | 0 |
| PLF | Bone Wedge | 2 | 1 | 2 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 2 | 3 | 0 |
| QNI | Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair | 2 | 1 | 2 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 | 0 |
| HTW | Bit, Drill | 1 | 0 | 2 |
| HWA | Impactor | 1 | 0 | 2 |
| HWX | Tap, Bone | 1 | 0 | 2 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | 2 | 1 | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 2 | 2 | 0 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 2 | 1 | 1 |
| MBB | Bone Cement, Antibiotic | 2 | 0 | 2 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 2 | 0 | 2 |
| OWI | Bone Fixation Cerclage, Sublaminar | 2 | 2 | 0 |
| PEK | Spinous Process Plate | 2 | 2 | 0 |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 2 | 2 | 0 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 | 2 | 0 |
| PML | Bone Cement, Posterior Screw Augmentation | 2 | 2 | 0 |
| HXI | Passer, Wire, Orthopedic | 1 | 0 | 1 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 2 | 0 | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 3 | 0 | 1 |
| JDO | Device, Fixation, Proximal Femoral, Implant | 2 | 1 | 0 |
| JDQ | Cerclage, Fixation | 2 | 1 | 0 |
| JDW | Pin, Fixation, Threaded | 2 | 1 | 0 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 2 | 1 | 0 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 2 | 0 | 1 |
| LGE | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing | 2 | 0 | 1 |
| LOF | Stimulator, Bone Growth, Non-Invasive | 2 | 1 | 0 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 2 | 1 | 0 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 0 | 1 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 1 | 0 |
| NPJ | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 0 | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | 1 | 0 |
| NWN | Laparoscopic Bone Anchor Urethropexy Instrument Kit | 2 | 0 | 1 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | 2 | 1 | 0 |
| OQB | Intervertebral Body Graft Containment Device | 2 | 1 | 0 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | 2 | 1 | 0 |
| OSN | Software For Diagnosis/Treatment | 2 | 1 | 0 |
| OYK | Ankle Arthroplasty Implantation System | 2 | 0 | 1 |
| PGM | Growing Rod System | 2 | 1 | 0 |
| PQC | Pedicle Screw Placement Guide | 2 | 1 | 0 |
| QLR | Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices | 2 | 1 | 0 |
| QVL | Absorbable Gel For Intraoperative Use In Spine Surgery | 2 | 1 | 0 |
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | 2 | 1 | 0 |
| SGL | Manual Instruments Designed For Use With Non-Fusion Spinous Process Tension Band Implant | 2 | 1 | 0 |
| SIN | Automated Intraoperative Spinal Rod Bending System | 2 | 1 | 0 |
| SIQ | Intra-Articular Orthopedic Stereotaxic Navigation Instrument | 2 | 1 | 0 |
| SIT | Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System | 2 | 1 | 0 |
| SJA | Injectable For Thermal Treatment Of Musculoskeletal Pain | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Smith & Nephew, Inc. EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM
REF72463106 Open, Classified |
HRS | K170457 K210837 +1 |
| Oct 22, 2026 | restor3d Inc. Generic Name: restor3d MTP Implant
Generic Name: MTP Implant
Model/Catalog Number: 1103-161620
Software Version: None
Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, Open, Classified |
KWD | K201393 |
| Oct 14, 2026 | In2bones USA, LLC REF: P65 ST862
CoLag SCREW, FT, 6.7X62.5 mm Open, Classified |
HWC | K170518 |
| Oct 9, 2026 | SI-BONE, Inc. iFuse TORQ Implant System
Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm) Open, Classified |
OUR | K203247 |
| Oct 9, 2026 | Medtronic Sofamor Danek USA Inc Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue
combined with an inert additive to yield a demineralized bone matrix (DBM)
allograft product having a particular physical for Open, Classified |
MBP | K051188 K051195 |
| Oct 9, 2026 | Medtronic Sofamor Danek USA Inc Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue
combined with an inert additive to yield a demineralized bone matrix (DBM)
allograft product having a particular physical f Open, Classified |
MBP | K042707 K043048 |
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Oct 6, 2026 | Onkos Surgical, Inc. Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left
REF PV-ACREC-04M Open, Classified |
LPH | K212815 K223348 |
| Oct 1, 2026 | Wright Medical Technology, Inc. CHARLOTTE CLAW Screw, REF: 40122716, intended for use with CLAW II Polyaxial Compression Plating System Open, Classified |
HRS | K133715 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl Open, Classified |
LOD | K213812 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suit Open, Classified |
MBB | K210607 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suita Open, Classified |
MBB | K210607 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.
Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable Open, Classified |
LOD | K210607 |
| Sep 18, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Mariner Deformity
Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm
REF: MD1-300010-12 Open, Classified |
NKB | K211606 |
| Sep 17, 2026 | F & A Foundation Reign Medical Clench Staple System (Compression), Description/REF:
9mm x 7mm/152-30907;
11mm x 10mm/152-31110;
15mm x 12mm/152-31512;
18mm x 18mm/152-31818;
20mm x 20mm/152-32020;
9mm x 7mm/152-4090 Open, Classified |
JDR | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO C-DOME PATELLA
73-2710
73-2910
SCORPIO U-DOME PATELLA
73-3110
73-3508
73-3708
73-3710
73-3910
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
NPJ | K051948 K052917 +2 |
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIDENT 0 POLY INSERT 28mm ID
620-00-28D
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MEH | K983502 |
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO RECESSED METAL BACKED PATELLA
3045-0026
3045-0028
3045-0030
3045-0032
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
MBH | K033972 |
| Sep 16, 2026 | Howmedica Osteonics Corp. BEARING AND AXLE BUSHING ASSY STD ELBOW
C-M113-1-301
KRH REV TIB INS 16mm THK .640 DIA STEM
C-M113-5-600
SELF-PRESSURIZING GLENOID SIZE 9
C-M063-5-800
Orthopaedic implant components manufa Open, Classified |
LGE | None listed |
| Sep 16, 2026 | Howmedica Osteonics Corp. ACETABULAR CUP UHMWPE
61-3258
ALL POLY CONSTRAINED INSERT 44MM
69-2244
ALL POLY CONSTRAINED INSERT 46MM
69-2246
ALL POLY CONSTRAINED INSERT 48MM
69-2248
ALL POLY CONSTRAINED INSERT 50M Open, Classified |
KWZ | K261624 |
| Sep 16, 2026 | Howmedica Osteonics Corp. DURACON XL ANGLED TIB INS 11/14MM
C-M064-1-300
SELF-PRESSURIZING GLENOID SIZE 8
C-M062-6-800
C-M062-7-500
C-M063-2-600
SELF-PRESSURIZING GLENOID SIZE 9
C-M063-5-000
SHOULDER - GLENOID # Open, Classified |
KWS | K962082 |
| Sep 16, 2026 | Howmedica Osteonics Corp. ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm
C-M079-2-801
ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID
C-M071-6-700
ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD
C-M071-8- Open, Classified |
KWL | K261624 |
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIATHLON HINGE INSERT SIZE 4 11MM
5612-P-411
TRIATHLON HINGE INSERT SIZE 4 13MM
5612-P-413
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
KRO | K223528 |
| Sep 16, 2026 | Howmedica Osteonics Corp. ALL POLY CONSTRAINED INSERT 54MM
69-2854
NRG KNEE CR
82-2-0512
82-2-0518
82-2-0912
NRG KNEE P/S
82-3-0318
SCORPIO + MOBILE BEARING PCS
78-5-0910
SCORPIO C-DOME PATELLA
73-2710
SC Open, Classified |
JWH | K243817 |
| Sep 16, 2026 | Howmedica Osteonics Corp. OMNIFIT SERIES I ACET. INSERT 10 22mm ID
Catalog No. 2001-2246
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
JDL | K850352 K900438 |
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