Depuy Orthopaedics Inc.
Raynham, MA, US
DEPUY ORTHOPAEDICS, INC. appears in FDA device records in Raynham, MA. FDA records list 209 510(k) clearances between and , 152 PMA records and 3 registered establishments. As of , FDA records show 740 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 209FDA records hold 209 510(k) clearances for Depuy Orthopaedics Inc. between 1998 and 2026. The busiest year on record is 2000, with 22. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 13 |
| 1999 | 5 |
| 2000 | 22 |
| 2001 | 19 |
| 2002 | 6 |
| 2003 | 13 |
| 2004 | 15 |
| 2005 | 10 |
| 2006 | 20 |
| 2007 | 21 |
| 2008 | 16 |
| 2009 | 14 |
| 2010 | 8 |
| 2011 | 8 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 5 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252887 | DePuy ATTUNE™ Knee System | OIY | Substantially Equivalent | |
| K231503 | CUPTIMIZE™ Advanced | LLZ | Substantially Equivalent | |
| K213839 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | |
| K210167 | DELTA XTEND Reverse Shoulder System | PHX | Substantially Equivalent | |
| K203167 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | |
| K202472 | ACTIS Duofix Hip Prosthesis | LPH | Substantially Equivalent | |
| K201347 | DePuy ATTUNE™ Total Knee System | OIY | Substantially Equivalent | |
| K193540 | TRUMATCH Personalized Solutions | JWH | Substantially Equivalent | |
| K193398 | Summit DuoFix HA Coating | MEH | Substantially Equivalent | |
| K192946 | DePuy Corail AMT Hip Prosthesis | LZO | Substantially Equivalent | |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | LPH | Substantially Equivalent | |
| K182301 | PFC SIGMA Knee System | JWH | Substantially Equivalent | |
| K170339 | Summit Hip System | LZO | Substantially Equivalent | |
| K150862 | DePuy Actis Duofox Hip Prosthesis | MEH | Substantially Equivalent | |
| K132959 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | LPH | Substantially Equivalent | |
| K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS | LPH | Substantially Equivalent | |
| K123924 | DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS | LZO | Substantially Equivalent | |
| K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS | HSN | Substantially Equivalent | |
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | HRS | Substantially Equivalent | |
| K112218 | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS | KTT | Substantially Equivalent | |
| K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | OIY | Substantially Equivalent | |
| K110397 | TRUMATCH PERSONALIZED SOLUTIONS | JWH | Substantially Equivalent | |
| K111077 | ORTHOSORB RESORBABLE PINS | OVZ | Substantially Equivalent | |
| K111444 | UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION | HSB | Substantially Equivalent | |
| K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM | OIY | Substantially Equivalent | |
| K093736 | DEPUY CORAIL HIP SYSTEM, REVISION STEM | LZO | Substantially Equivalent | |
| K103001 | ROCKWOOD CLAVICLE PINS | JDW | Substantially Equivalent | |
| K103408 | POSTERIOR LATERAL PLATES | HRS | Substantially Equivalent | |
| K101433 | DEPUY ATTUNE KNEE SYSTEM | OIY | Substantially Equivalent | |
| K102423 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | LPH | Substantially Equivalent | |
| K100391 | DEPUY UNIVERSAL GRIPTION TF CONES | JWH | Substantially Equivalent | |
| K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 | HRS | Substantially Equivalent | |
| K101421 | MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204 | HRS | Substantially Equivalent | |
| K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM | HSB | Substantially Equivalent | |
| K093474 | DEPUY FRACTURE AND FUSION PLATING SYSTEM | HRS | Substantially Equivalent | |
| K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | JDI | Substantially Equivalent | |
| K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 | KRO | Substantially Equivalent | |
| K092122 | GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID | KWS | Substantially Equivalent | |
| K091294 | LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, | HRS | Substantially Equivalent | |
| K091751 | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP | KWS | Substantially Equivalent | |
| K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS | HRS | Substantially Equivalent | |
| K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | JDI | Substantially Equivalent | |
| K090492 | 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS | HRS | Substantially Equivalent | |
| K083789 | ACE FISCHER EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | |
| K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | HRS | Substantially Equivalent | |
| K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | LXT | Substantially Equivalent | |
| K083642 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | KWA | Substantially Equivalent | |
| K082300 | ANATOMIC LOCKING PLATING SYSTEM | HRS | Substantially Equivalent | |
| K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | KYJ | Substantially Equivalent | |
| K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | HSD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004464325 | 3004464325 | DEPUY ORTHOPAEDICS | 50 SCOTLAND BLVD., BRIDGEWATER, MA 02324 US | 2026 | and 144 more, listed in full below |
| 1219655 | 1219655 | DEPUY ORTHOPAEDICS, INC. | 325 PARAMOUNT DR., RAYNHAM, MA 02767 US | 2026 | and 66 more, listed in full below |
| 1818910 | 1818910 | DEPUY ORTHOPAEDICS, INC. | 700 ORTHOPAEDIC DR., WARSAW, IN 46582 US | 2026 | and 122 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGXAlkaline Picrate, Colorimetry, Creatinine
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- GEFApplier, Staple, Surgical,
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- GFFBur, Surgical, General & Plastic Surgery
- GEACannula, Surgical, General & Plastic Surgery
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- GBXCatheter, Irrigation
- FZOChisel, Surgical, Manual
- GXRCover, Burr Hole
- FXPCover, Shoe, Operating-Room
- FZTCutter, Surgical
- GDIDissector, Surgical, General & Plastic Surgery
- FYEDress, Surgical
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- GFCDriver, Surgical, Pin
- DZJDriver, Wire, And Bone Drill, Manual
- GXQDura Substitute
- GXZElectrode, Needle
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- GEGElevator, Surgical, General & Plastic Surgery
- GENForceps, General & Plastic Surgery
- GDHGouge, Surgical, General & Plastic Surgery
- FYAGown, Surgical
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- GDZHandle, Scalpel
- FXZHelmet, Surgical
- GDGHook, Surgical, General & Plastic Surgery
- FQPLamp, Operating-Room
- GCJLaparoscope, General & Plastic Surgery
- FQHLavage, Jet
- FCWLight Source, Fiberoptic, Routine
- FSQLight, Surgical, Instrument
- GFJMallet, Surgical, General & Plastic Surgery
- FTMMesh, Surgical
- EZXMesh, Surgical, Metal
- FTLMesh, Surgical, Polymeric
- GXPMethyl Methacrylate For Cranioplasty
- GEYMotor, Surgical Instrument, Ac-Powered
- GAANeedle, Aspiration And Injection, Disposable
- GABNeedle, Suturing, Disposable
- GFIOsteotome, Manual
- GWOPlate, Cranioplasty, Preformed, Alterable
- BTAPump, Portable, Aspiration (Manual Or Powered)
- GACRasp, Surgical, General & Plastic Surgery
- GADRetractor
- FDGRetractor, Fiberoptic
- GZTRetractor, Self-Retaining, For Neurosurgery
- HABSaw, Powered, And Accessories
- GDXScalpel, One-Piece
- DZLScrew, Fixation, Intraosseous
- ETNStimulator, Nerve
- FMFSyringe, Piston
- BWNTable And Attachments, Operating-Room
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
Recall records
Showing 25 of 740| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1456-2024 | ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System. | Product incorrectly labelled. | Class II | Open, Classified | |
| Z-1267-2023 | Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507 | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. | Class II | Open, Classified | |
| Z-1266-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312 | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. | Class II | Open, Classified | |
| Z-1265-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226 | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. | Class II | Open, Classified | |
| Z-1264-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212 | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. | Class II | Open, Classified | |
| Z-1263-2023 | Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118 | The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties. | Class II | Open, Classified | |
| Z-1419-2022 | 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 | Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain | Class II | Open, Classified | |
| Z-1375-2022 | MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000 | The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures. | Class II | Open, Classified | |
| Z-1029-2022 | VELYS Robotic-Assisted Solution Base Product No.: 451570100 | System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment | Class II | Terminated | |
| Z-0632-2022 | ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001 | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. | Class II | Terminated | |
| Z-0631-2022 | ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003 | May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur. | Class II | Terminated | |
| Z-0490-2022 | GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0489-2022 | GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0488-2022 | GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0487-2022 | GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0486-2022 | GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0485-2022 | GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0484-2022 | GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0483-2022 | GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610 | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage | Class II | Terminated | |
| Z-0074-2022 | ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001 | Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery | Class II | Terminated | |
| Z-2400-2021 | 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 intra-operatively and in guiding the marking of bone before cutting Part Number: 420917 | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment. | Class II | Terminated | |
| Z-2399-2021 | 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 intra-operatively and in guiding the marking of bone before cutting Part Number: 420916 | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment. | Class II | Terminated | |
| Z-2398-2021 | 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 intra-operatively and in guiding the marking of bone before cutting Part Number: 420915 | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment. | Class II | Terminated | |
| Z-2397-2021 | 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 intra-operatively and in guiding the marking of bone before cutting Part Number: 420907 | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment. | Class II | Terminated | |
| Z-2396-2021 | 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 intra-operatively and in guiding the marking of bone before cutting Part Number: 420581 | Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain