Company · US
Biomet, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2026. Name variants (Inc, Corp, punctuation) are merged.
445510(k) clearances (2 in 12 months)
547recalls (5 in 12 months)
386recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 87 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 84 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 78 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 69 |
| LXH | Orthopedic Manual Surgical Instrument | 53 |
| HWC | Screw, Fixation, Bone | 51 |
| HRS | Plate, Fixation, Bone | 49 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 45 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 29 |
| HTO | Reamer | 25 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 25 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 25 |
| HTZ | Instrument, Cutting, Orthopedic | 21 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 21 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 20 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 15 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 15 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 12 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 12 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 11 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2026 | K253434 | OSSTM Orthopedic Salvage System Biomet, Inc. | JDI |
| May 19, 2026 | K251270 | Taperloc® Complete Hip Stem Biomet, Inc. | LPH |
| May 22, 2024 | K241014 | Biomet Kirschner Wires (K-Wires) Biomet, Inc. | HTY |
| Dec 28, 2022 | K222760 | StageOne Select Hip Cement Spacer Molds Biomet, Inc. | MBB |
| Sep 15, 2022 | K221968 | StageOne Shoulder Cement Spacer Molds Biomet, Inc. | MBB |
| Sep 2, 2022 | K213287 | StageOne Knee Cement Spacer Molds Biomet, Inc. | MBB |
| Feb 7, 2022 | K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve Biomet, Inc. | JDG |
| Dec 10, 2021 | K212435 | Comprehensive Humeral Fracture Positioning Sleeves Biomet, Inc. | KWS |
| Feb 19, 2021 | K210192 | A.L.P.S. Clavicle Plating System Biomet, Inc. | HRS |
| Nov 10, 2020 | K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist Biomet, Inc. | MBI |
| Sep 25, 2020 | K193546 | Distal Centralizers Biomet, Inc. | JDG |
| Apr 15, 2020 | K193373 | Comprehensive® Reverse Shoulder Biomet, Inc. | PHX |
| Mar 5, 2020 | K193402 | ALLthread PEEK Suture Anchor Biomet, Inc. | MBI |
| Feb 24, 2020 | K193451 | Titanium Interference Screws Biomet, Inc. | HWC |
| Feb 20, 2020 | K193533 | WIN Flexible Nail System Biomet, Inc. | JDS |
| Jan 16, 2020 | K192942 | ALLthread Titanium Suture Anchor Biomet, Inc. | MBI |
| Jan 2, 2020 | K193092 | TunneLoc Tibial Fixation Device Biomet, Inc. | MBI |
| Sep 13, 2019 | K191459 | JuggerStitch Meniscal Repair Device Biomet, Inc. | MBI |
| Feb 7, 2019 | K190035 | Biomet Headless Compression and Twist-Off Screws Biomet, Inc. | HWC |
| Jan 22, 2019 | K183553 | Compress and Mini Compress Anti-Rotation Spindles Biomet, Inc. | MBF |
| Dec 14, 2018 | K183162 | Affixus Hip Fracture Nail Biomet, Inc. | HSB |
| Apr 6, 2018 | K173767 | A. L. P. S. Clavicle Plating System Biomet, Inc. | HRS |
| Feb 7, 2018 | K173826 | THP Hip Fracture Plating System Biomet, Inc. | JDO |
| Jan 5, 2018 | K173278 | ToggleLoc System Biomet, Inc. | MBI |
| Oct 5, 2017 | K172408 | Biomet Bone Cement R Biomet, Inc. | LOD |
| Aug 30, 2017 | K171540 | Refobacin Bone Cement R Biomet, Inc. | LOD |
| Jul 28, 2017 | K171054 | Biomet Knee Joint Replacement Prostheses Biomet, Inc. | JWH |
| Mar 31, 2017 | K162559 | Move Forward 3D Motion Simulation Service Biomet, Inc. | LLZ |
| Jan 25, 2017 | K161273 | StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis Biomet, Inc. | MBB |
| Nov 3, 2016 | K161592 | Persona Partial Knee System Biomet, Inc. | HSX |
| Oct 12, 2016 | K162424 | Ulna Plating System Biomet, Inc. | HRS |
| Sep 8, 2016 | K161166 | StageOne Select Cement Spacer Molds for Temporary Hip Replacement Biomet, Inc. | MBB |
| Jun 16, 2016 | K160071 | StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis Biomet, Inc. | MBB |
| May 26, 2016 | K161190 | G7 Dual Mobility System, Active Articulation System Biomet, Inc. | LPH |
| May 10, 2016 | K153657 | Vanguard XP Knee System Biomet, Inc. | MBH |
| Mar 9, 2016 | K160058 | Biomet Variable Pitch Compression Screw System Biomet, Inc. | HWC |
| Oct 14, 2015 | K152621 | OSS/Arcos IM Total Femur Rod Biomet, Inc. | JDI |
| Oct 6, 2015 | K151603 | Arcos One-piece Femoral Revision System Biomet, Inc. | LPH |
| Jul 16, 2015 | K150850 | Refobacin Bone Cement R Biomet, Inc. | MBB |
| Jun 10, 2015 | K150867 | Affixus Tibial Nailing System Biomet, Inc. | HSB |
| May 1, 2015 | K150522 | G7 Dual Mobility System Biomet, Inc. | LPH |
| Mar 25, 2015 | K150503 | Echo Bi-Metric Microplasty Line Extension Biomet, Inc. | LPH |
| Feb 12, 2015 | K143192 | Vanguard 360 Revision Knee System Biomet, Inc. | JWH |
| Feb 10, 2015 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 Biomet, Inc. | LPH |
| Jan 30, 2015 | K143543 | Prelude PF Patellae Biomet, Inc. | KRR |
| Dec 23, 2014 | K142933 | Biomet Tibial trays Biomet, Inc. | JWH |
| Dec 18, 2014 | K143009 | Echo Bi-Metric Microplasty Hip System Biomet, Inc. | LPH |
| Dec 11, 2014 | K140669 | G7 OSSEOTI ACETUBLAR SHELLS Biomet, Inc. | LPH |
| Oct 27, 2014 | K141407 | VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL Biomet, Inc. | MBH |
| Oct 27, 2014 | K141331 | BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) Biomet, Inc. | JDI |
Newest 50 of 445.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475640
Product Description: Intramedullary Bone Saw Blade Assembly 16mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475635
Product Description: Intramedullary Bone Saw Blade Assembly 15mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475630
Product Description: Intramedullary Bone Saw Blade Assembly 14mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475625
Product Description: Intramedullary Bone Saw Blade Assembly 13mm Open, Classified |
LXH | None listed |
| Aug 3, 2026 | Biomet, Inc. Intramedullary Bone Saw Blade Assembly
Model/Catalog Number: 475620
Product Description: Intramedullary Bone Saw Blade Assembly 12mm Open, Classified |
LXH | None listed |
| Oct 17, 2025 | Biomet, Inc. BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair Open, Classified |
MBI | K130033 |
| Sep 23, 2025 | Biomet, Inc. Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080 Open, Classified |
MBI | K110879 |
| Nov 15, 2024 | Biomet, Inc. JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 Open, Classified |
KDD | None listed |
| Jun 25, 2024 | Biomet, Inc. RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty
Item Number: 11-165206 Open, Classified |
JDI | K051569 |
| Apr 22, 2024 | Biomet, Inc. Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a
polyurethane bag, and sealed Open, Classified |
MBH | K050222 |
| Dec 18, 2023 | Biomet, Inc. Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02 Open, Classified |
LZO | K200112 |
| Dec 18, 2023 | Biomet, Inc. Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01 Open, Classified |
LZO | K200112 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 28 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178570 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 26 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178568 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178566 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 23 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178565 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178564 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178562 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178560 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 16 MM- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous
joint replacement
Item Number: 178558 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178556 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178554 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Short Anchor Plug, 10 MM-Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Item Number: 178552 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178414 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 22 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178412 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178410 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 18 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178408 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 16 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178406 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178404 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178402 Open, Classified |
KWA | K062998 |
| Nov 21, 2023 | Biomet, Inc. Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Item Number: 178400 Open, Classified |
KWA | K062998 |
| Mar 23, 2023 | Biomet, Inc. G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462 Open, Classified |
LPH | K150522 |
| Jan 30, 2023 | Biomet, Inc. (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122
EXPANDED RECALL:
(2) Vanguard Knee System PS Open Box Femoral; Left; Open, Classified |
JWH | K113550 |
| Jan 30, 2023 | Biomet, Inc. (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses.
Item Number: 183104
(2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm
Item Numb Open, Classified |
JWH | K113550 |
| Jan 27, 2023 | Biomet, Inc. OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee
Item Open, Classified |
HSB | K042409 |
| Jan 26, 2023 | Biomet, Inc. Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component
Item Number: 154341 Open, Classified |
HRY | K133940 |
| Feb 14, 2022 | Biomet, Inc. BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X Terminated |
JDR | None listed |
| Feb 14, 2022 | Biomet, Inc. BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient re Terminated |
JDR | K111663 |
| Feb 14, 2022 | Biomet, Inc. BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Terminated |
JDR | K133939 |
| Feb 14, 2022 | Biomet, Inc. BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, Terminated |
JDR | K141263 |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long
Item Number: 113635 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long
Item Number: 113633 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long
Item Number: 113632 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long
Item Number: 113631 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Primary Shoulder Stem,
Micro Length, Porous Plasma, 18 MM, 55 MM Long
Item Number: 113618 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Primary Shoulder Stem,
Micro Length, Porous Plasma, 14 MM, 55 MM Long
Item Number: 113614 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long
Item Number: 113611 Terminated |
MBF | None listed |
| Jan 7, 2022 | Biomet, Inc. Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM
Item Number: 11-301301 Terminated |
MBF | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM
Item Number: 11-301354 Terminated |
KWA | K090757 |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM
Item Number: 11-301343 Terminated |
KWA | K090757 |
Newest 50 of 547.