DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc. holds FDA 510(k) medical device clearances, first cleared 1998, most recent 2026, with 155 FDA device recalls on record.
Name variants for DePuy Orthopaedics, Inc.
as filed with FDA- DePuy Orthopaedics, Inc.
- Depuy Orthopaedics, Inc.
Top product codes for DePuy Orthopaedics, Inc.
FDA recalls by DePuy Orthopaedics, Inc.
10 most recent of 155- Z-1456-2024 — ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
- Z-1265-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
- Z-1263-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
- Z-1267-2023 — Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
- Z-1266-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
- Z-1264-2023 — Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
- 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
- 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
- Z-1029-2022 — VELYS Robotic-Assisted Solution Base Product No.: 451570100
- 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
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by DePuy Orthopaedics, Inc.
1–100 of 208- K262130 — ATTUNE Revision Knee System
- K252887 — DePuy ATTUNE Knee System
- K231503 — CUPTIMIZE Advanced
- K213839 — DePuy Corail AMT Hip Prosthesis
- K210167 — DELTA XTEND Reverse Shoulder System
- K203167 — DePuy Corail AMT Hip Prosthesis
- K202472 — ACTIS Duofix Hip Prosthesis
- K201347 — DePuy ATTUNE Total Knee System
- K193540 — TRUMATCH Personalized Solutions
- K193398 — Summit DuoFix HA Coating
- K192919 — Pinnacle Duofix HA Acetabular Cup Prosthesis
- K192946 — DePuy Corail AMT Hip Prosthesis
- K182301 — PFC SIGMA Knee System
- K170339 — Summit Hip System
- K150862 — DePuy Actis Duofox Hip Prosthesis
- K132959 — DEPUY PINNACLE ALTRX ACETABULAR LINERS
- K122395 — DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
- K111663 — TRAUMA INTERNAL FIXATION SYSTEMS
- K112218 — ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS
- K111433 — DEPUY STTUNE (TM) PS KNEE SYSTEM
- K110397 — TRUMATCH PERSONALIZED SOLUTIONS
- K111077 — ORTHOSORB RESORBABLE PINS
- K111444 — UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
- K103756 — DEPUY ATTUNE TOTAL KNEE SYSTEM
- K093736 — DEPUY CORAIL HIP SYSTEM, REVISION STEM
- K103001 — ROCKWOOD CLAVICLE PINS
- K103408 — POSTERIOR LATERAL PLATES
- K101433 — DEPUY ATTUNE KNEE SYSTEM
- K102423 — DEPUY PINNACLE ALTRX ACETABULAR LINERS
- K100391 — DEPUY UNIVERSAL GRIPTION TF CONES
- K101240 — CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467
- K101421 — MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708; 851318704-708, 131218204
- K100238 — HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
- K093474 — DEPUY FRACTURE AND FUSION PLATING SYSTEM
- K093646 — DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
- K091453 — LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
- K092122 — GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID
- K091294 — LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
- K091751 — DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
- K090877 — PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS
- K090998 — DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
- K090492 — 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
- K083789 — ACE FISCHER EXTERNAL FIXATION SYSTEM
- K083843 — LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
- K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
- K083642 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K082300 — ANATOMIC LOCKING PLATING SYSTEM
- K083107 — MODIFICATION TO DEPUY NEUFLEX PIP FINGER
- K082715 — DEPUY GLOBAL AP CTA HUMERAL HEAD
- K083364 — 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424
- K082585 — DEPUY ASPHERE M-SPEC HEAD
- K082500 — DEPUY SIGMA CR-F FEMORAL COMPONENT
- K082239 — DEPUY C-STEM AMT
- K081546 — SMALL BONE LOCKING PLATING SYSTEM
- K080990 — DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER
- K080991 — DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
- K081620 — MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM
- K081155 — SMARTSET MV BONE CEMENT
- K081163 — SMARTSET GMV GENTAMICIN BONE CEMENT
- K073570 — DEPUY TRI-LOCK BONE PRESERVATION STEM
- K073413 — DEPUY ASR 300 ACETABULAR CUP SYSTEM
- K073676 — DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP
- K073529 — DEPUY SIGMA PS FEMORAL COMPONENTS
- K072963 — DEPUY PINNACLE ALTRX ACETABULAR LINERS
- K063686 — DEPUY LPS DISTAL FEMORAL COMPONENT
- K072832 — ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
- K071059 — DEPUY SPA POROUS COATED PROXIMAL SLEEVE
- K072423 — 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY.
- K072083 — SMALL FRAGMENT LOCKING PLATING SYSTEM
- K071830 — DEPUY DELTA TS CERAMIC FEMORAL HEADS
- K070554 — DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
- K071379 — DELTA XTEND REVERSE SHOULDER MODULAR STEM
- K071016 — DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
- K070267 — DEPUY GCK TIBIAL COMPONENTS
- K071417 — DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
- K071784 — DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
- K071334 — DEPUY CAS HEMI ASR HIP INSTRUMENTS
- K070849 — DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
- K071135 — DEPUY CI HIP INSTRUMENTATION
- K071117 — MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS
- K070359 — DEPUY ASR TAPER SLEEVE ADAPTER
- K063633 — DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
- K062250 — DELTA XTEND REVERSE SHOULDER SYSTEM
- K063652 — GLOBAL AP POROUS COATED HUMERAL STEM
- K063509 — DEPUY PEAK FX HIP PLATE
- K062426 — DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
- K062748 — MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
- K062148 — DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
- K062352 — FRS SCREW
- K062301 — DEPUY LPS PROXIMAL TIBIAL COMPONENT
- K062654 — DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS
- K061648 — DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
- K061221 — DUPUY S-ROM STD HIP STEM PROSTHESIS
- K062116 — DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS
- K061833 — DEPUY AML HIP PROSTHESIS
- K060874 — DEPUY GLOBAL AP SHOULDER SYSTEM
- K061144 — DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT
- K060746 — MEMORY STAPLE
- K060581 — DEPUY SOLUTION SYSTEM HIP PROSTHESIS
- K060969 — POLYAX LOCKED PLATING SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.