Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Howmedica Osteonics Corp. — Predicate Candidate Screening
288 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
142 days90th percentile
288clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit Cup | Howmedica Osteonics Corp. | 2020-08-13 | 247 | 1 |
| K200782 | Triathlon Posterior Stabilized Femoral Component - beaded wi | Howmedica Osteonics Corp. | 2020-05-13 | 48 | 0 |
| K130895 | REUNION RSA SHOULDER SYSTEM | Howmedica Osteonics Corp. | 2013-12-27 | 270 | 0 |
| K123604 | ABG III MONOLITHIC HIP STEM | Howmedica Osteonics Corp. | 2013-08-16 | 268 | 1 |
| K122015 | DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENT | Howmedica Osteonics Corp. | 2013-02-22 | 227 | 0 |
| K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL | Howmedica Osteonics Corp. | 2013-02-14 | 128 | 0 |
| K122853 | NOVEL FIT AND FILL STEM | Howmedica Osteonics Corp. | 2013-02-01 | 136 | 0 |
| K121315 | STRYKER CMF MEDPOR CUSTOMIZED IMPLANT | Howmedica Osteonics Corp. | 2012-11-01 | 183 | 0 |
| K121308 | HIP SYSTEMS | Howmedica Osteonics Corp. | 2012-07-30 | 90 | 1 |
| K113409 | S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAI | Howmedica Osteonics Corp. | 2012-02-15 | 89 | 0 |
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | Howmedica Osteonics Corp. | 2011-09-28 | 26 | 1 |
| K110290 | EXETER HIP STEM | Howmedica Osteonics Corp. | 2011-09-27 | 238 | 1 |
| K103835 | REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL | Howmedica Osteonics Corp. | 2011-05-05 | 126 | 1 |
| K101072 | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITA | Howmedica Osteonics Corp. | 2011-04-11 | 357 | 0 |
| K103233 | MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT | Howmedica Osteonics Corp. | 2011-02-03 | 93 | 1 |
| K102992 | T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / | Howmedica Osteonics Corp. | 2010-12-22 | 75 | 0 |
| K103104 | SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT | Howmedica Osteonics Corp. | 2010-11-22 | 33 | 0 |
| K100884 | STRYKER KNIFELIGHT | Howmedica Osteonics Corp. | 2010-06-25 | 87 | 0 |
| K101438 | T2 GREATER TROCHANTER NAIL | Howmedica Osteonics Corp. | 2010-06-17 | 24 | 2 |
| K100271 | VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES | Howmedica Osteonics Corp. | 2010-05-14 | 105 | 0 |
| K101056 | VARIAX ELBOW SYSTEM | Howmedica Osteonics Corp. | 2010-05-13 | 28 | 0 |
| K100475 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING IN | Howmedica Osteonics Corp. | 2010-04-30 | 71 | 0 |
| K091955 | STRYKER SONICPIN SYSTEM | Howmedica Osteonics Corp. | 2010-04-02 | 275 | 0 |
| K093433 | VARIAX ELBOW SYSTEM PLATE LINE EXTENSION | Howmedica Osteonics Corp. | 2010-01-28 | 85 | 0 |
| K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR | Howmedica Osteonics Corp. | 2009-12-18 | 23 | 1 |
| K092178 | AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE | Howmedica Osteonics Corp. | 2009-11-20 | 122 | 0 |
| K092406 | ABG II MODULAR HIP STEM | Howmedica Osteonics Corp. | 2009-11-04 | 90 | 1 |
| K090897 | TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT | Howmedica Osteonics Corp. | 2009-10-23 | 205 | 0 |
| K092561 | REJUVENATE MODULAR STEM | Howmedica Osteonics Corp. | 2009-10-20 | 60 | 1 |
| K092834 | HOFFMAN XPRESS LINE EXTENSION | Howmedica Osteonics Corp. | 2009-10-08 | 23 | 0 |
| K092671 | VARIAX ELBOW SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | 2009-09-23 | 23 | 0 |
| K092419 | AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING IN | Howmedica Osteonics Corp. | 2009-09-01 | 26 | 0 |
| K091161 | REJUVENATE MONOLITHIC SIZE 4 HIP STEM | Howmedica Osteonics Corp. | 2009-06-16 | 56 | 0 |
| K082892 | REJUVENATE MONOLITHIC HIP SYSTEM | Howmedica Osteonics Corp. | 2008-12-29 | 90 | 0 |
| K083437 | MODIFICATION TO T2 RECON NAIL SYSTEM | Howmedica Osteonics Corp. | 2008-12-18 | 28 | 0 |
| K082018 | T2 FLEXIBLE NAIL | Howmedica Osteonics Corp. | 2008-10-10 | 86 | 0 |
| K082567 | STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION | Howmedica Osteonics Corp. | 2008-10-03 | 29 | 0 |
| K081171 | TRITANIUM ACETABULAR SHELL SYSTEM | Howmedica Osteonics Corp. | 2008-07-22 | 89 | 0 |
| K081284 | VARIAX DISTAL FIBULA PLATE | Howmedica Osteonics Corp. | 2008-07-18 | 73 | 0 |
| K081152 | T2 FEMORAL NAIL | Howmedica Osteonics Corp. | 2008-06-10 | 48 | 0 |
| K081044 | REJUVENATE MODULAR HIP SYSTEM | Howmedica Osteonics Corp. | 2008-06-03 | 50 | 0 |
| K081278 | OMEGA 3 TROCHANTERIC STABILIZING PLATE | Howmedica Osteonics Corp. | 2008-05-29 | 23 | 0 |
| K080667 | VARIAX DISTAL RADIUS TORX SCREWS | Howmedica Osteonics Corp. | 2008-03-19 | 9 | 0 |
| K073076 | HOFFMANN LIGHT SYSTEM | Howmedica Osteonics Corp. | 2008-02-15 | 107 | 0 |
| K073527 | VARIAX ELBOW SYSTEM | Howmedica Osteonics Corp. | 2008-02-14 | 59 | 0 |
| K072020 | RESTORATION ADM SYSTEM | Howmedica Osteonics Corp. | 2007-10-18 | 87 | 1 |
| K072221 | MODIFICATION TO TRIATHLON TS KNEE SYSTEM | Howmedica Osteonics Corp. | 2007-10-15 | 66 | 0 |
| K071881 | TRIATHLON PKR SYSTEM | Howmedica Osteonics Corp. | 2007-10-09 | 92 | 1 |
| K071082 | STRYKER MODULAR HIP SYSTEM | Howmedica Osteonics Corp. | 2007-09-13 | 149 | 0 |
| K071471 | CORIN ADAPTOR SLEEVE | Howmedica Osteonics Corp. | 2007-09-10 | 104 | 1 |
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