Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OQG — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
144 daysmedian FDA review time
414 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | Microport Orthopedics, Inc. | 2021-08-20 | 338 | 0 |
| K203472 | KMTI Hip Replacement System | Kyocera Medical Technologies, Inc. | 2021-04-02 | 128 | 0 |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies | Kyocera Medical Technologies, Inc. | 2020-07-16 | 28 | 0 |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, | Kyocera Medical Technologies, Inc. | 2020-03-11 | 30 | 0 |
| K172651 | FMP Extended Liners | Encore Medical L.P. | 2017-12-13 | 99 | 0 |
| K171543 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies | 2017-11-16 | 174 | 0 |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klas | Total Joint Orthopedics, Inc. | 2017-10-27 | 28 | 0 |
| K143647 | Renovis Surgical Hip Replacement System | Renovis Surgical Technologies, Inc. | 2015-05-11 | 140 | 0 |
| K140130 | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, | Encore Medical L.P. | 2014-11-06 | 293 | 0 |
| K141972 | KLASSIC HD ACETABULAR INSERT WITH E-LINK POLY | Total Joint Orthopedics, Inc. | 2014-10-09 | 80 | 0 |
| K140701 | NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ H | Novosource, Inc. | 2014-06-27 | 99 | 0 |
| K130652 | VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT | Consensus Orthopedics, Inc. | 2013-12-17 | 280 | 0 |
| K122783 | PLASMAFIT ACETABULAR CUP AND VITELENE INSERT | Aesculap Implant System, Inc. | 2013-10-30 | 414 | 0 |
| K130365 | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | Encore Medical L.P. | 2013-09-23 | 222 | 0 |
| K122158 | PBP TOTAL HIP SYSTEM | Pipeline Biomedical Products, LLC | 2012-12-11 | 144 | 0 |
| K122773 | CROSS-OVER ACETABULAR SHELL & LINER | Stelkast Company | 2012-10-09 | 29 | 1 |
| K112897 | RENOVIS SURGICAL HIP JOINT REPLACEMENT PROSTHESIS | Renovis Surgical Technologies, LLC | 2012-06-13 | 254 | 0 |
| K120370 | VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS | Zimmer, Inc. | 2012-06-04 | 119 | 0 |
| K112802 | PIPELINE TOTAL HIP SYSTEM | Pipeline Orthopedics | 2012-03-09 | 164 | 0 |
| K094035 | EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 | Stelkast Company | 2011-03-24 | 449 | 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