Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DePuy Orthopaedics, Inc. · Predicate Candidate Screening
207 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
184 days90th percentile
207clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252887 | DePuy ATTUNE™ Knee System | DePuy Orthopaedics, Inc. | 2026-05-22 | 254 | 0 |
| K231503 | CUPTIMIZE™ Advanced | DePuy Orthopaedics, Inc. | 2023-08-22 | 90 | 0 |
| K213839 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | 2022-01-06 | 28 | 0 |
| K210167 | DELTA XTEND Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2021-02-19 | 29 | 0 |
| K203167 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020-11-19 | 27 | 0 |
| K202472 | ACTIS Duofix Hip Prosthesis | DePuy Orthopaedics, Inc. | 2020-10-21 | 54 | 0 |
| K201347 | DePuy ATTUNE™ Total Knee System | DePuy Orthopaedics, Inc. | 2020-06-18 | 28 | 0 |
| K193540 | TRUMATCH Personalized Solutions | DePuy Orthopaedics, Inc. | 2020-06-16 | 179 | 0 |
| K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020-02-04 | 60 | 0 |
| K192946 | DePuy Corail AMT Hip Prosthesis | DePuy Orthopaedics, Inc. | 2019-11-26 | 39 | 0 |
| K192919 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2019-11-26 | 42 | 0 |
| K182301 | PFC SIGMA Knee System | DePuy Orthopaedics, Inc. | 2019-11-08 | 441 | 0 |
| K170339 | Summit Hip System | DePuy Orthopaedics, Inc. | 2018-04-26 | 448 | 0 |
| K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015-09-25 | 177 | 1 |
| K132959 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2014-03-10 | 171 | 0 |
| K122395 | DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS | DePuy Orthopaedics, Inc. | 2012-10-31 | 85 | 0 |
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS | DePuy Orthopaedics, Inc. | 2012-03-12 | 272 | 15 |
| K112218 | ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIX | DePuy Orthopaedics, Inc. | 2011-12-15 | 135 | 0 |
| K111433 | DEPUY STTUNE (TM) PS KNEE SYSTEM | DePuy Orthopaedics, Inc. | 2011-08-30 | 99 | 1 |
| K110397 | TRUMATCH PERSONALIZED SOLUTIONS | DePuy Orthopaedics, Inc. | 2011-08-16 | 186 | 0 |
| K111077 | ORTHOSORB RESORBABLE PINS | DePuy Orthopaedics, Inc. | 2011-07-12 | 85 | 0 |
| K111444 | UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTEN | DePuy Orthopaedics, Inc. | 2011-06-22 | 29 | 0 |
| K103756 | DEPUY ATTUNE TOTAL KNEE SYSTEM | DePuy Orthopaedics, Inc. | 2011-03-15 | 82 | 0 |
| K093736 | DEPUY CORAIL HIP SYSTEM, REVISION STEM | DePuy Orthopaedics, Inc. | 2011-03-10 | 461 | 0 |
| K103001 | ROCKWOOD CLAVICLE PINS | DePuy Orthopaedics, Inc. | 2011-02-17 | 134 | 0 |
| K103408 | POSTERIOR LATERAL PLATES | DePuy Orthopaedics, Inc. | 2010-12-16 | 27 | 0 |
| K101433 | DEPUY ATTUNE KNEE SYSTEM | DePuy Orthopaedics, Inc. | 2010-12-10 | 203 | 0 |
| K102423 | DEPUY PINNACLE ALTRX ACETABULAR LINERS | DePuy Orthopaedics, Inc. | 2010-10-29 | 65 | 2 |
| K100391 | DEPUY UNIVERSAL GRIPTION TF CONES | DePuy Orthopaedics, Inc. | 2010-09-29 | 225 | 0 |
| K101240 | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021 | DePuy Orthopaedics, Inc. | 2010-07-23 | 80 | 0 |
| K101421 | MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OL | DePuy Orthopaedics, Inc. | 2010-06-15 | 26 | 0 |
| K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN R | DePuy Orthopaedics, Inc. | 2010-05-11 | 104 | 130 |
| K093474 | DEPUY FRACTURE AND FUSION PLATING SYSTEM | DePuy Orthopaedics, Inc. | 2010-02-02 | 88 | 1 |
| K093646 | DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009-12-17 | 22 | 0 |
| K091453 | LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-19872733 | DePuy Orthopaedics, Inc. | 2009-08-12 | 86 | 0 |
| K092122 | GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID | DePuy Orthopaedics, Inc. | 2009-07-27 | 13 | 0 |
| K091294 | LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSIO | DePuy Orthopaedics, Inc. | 2009-07-24 | 81 | 0 |
| K091751 | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP | DePuy Orthopaedics, Inc. | 2009-07-14 | 28 | 0 |
| K090877 | PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW P | DePuy Orthopaedics, Inc. | 2009-06-26 | 87 | 0 |
| K090998 | DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS | DePuy Orthopaedics, Inc. | 2009-06-12 | 65 | 0 |
| K090492 | 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCR | DePuy Orthopaedics, Inc. | 2009-03-31 | 34 | 0 |
| K083789 | ACE FISCHER EXTERNAL FIXATION SYSTEM | DePuy Orthopaedics, Inc. | 2009-03-23 | 94 | 0 |
| K083843 | LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM | DePuy Orthopaedics, Inc. | 2009-03-20 | 86 | 0 |
| K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S | DePuy Orthopaedics, Inc. | 2009-03-11 | 22 | 0 |
| K083642 | DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS | DePuy Orthopaedics, Inc. | 2009-03-06 | 87 | 0 |
| K082300 | ANATOMIC LOCKING PLATING SYSTEM | DePuy Orthopaedics, Inc. | 2009-02-18 | 190 | 2 |
| K083107 | MODIFICATION TO DEPUY NEUFLEX PIP FINGER | DePuy Orthopaedics, Inc. | 2009-02-09 | 112 | 0 |
| K082715 | DEPUY GLOBAL AP CTA HUMERAL HEAD | DePuy Orthopaedics, Inc. | 2008-12-18 | 92 | 0 |
| K083364 | 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-1312 | DePuy Orthopaedics, Inc. | 2008-12-11 | 28 | 0 |
| K082585 | DEPUY ASPHERE M-SPEC HEAD | DePuy Orthopaedics, Inc. | 2008-12-04 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda