Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Osteonics Corp. — Predicate Candidate Screening

178 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

84 daysmedian FDA review time

232 days90th percentile

178clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K983657	OSTEONICS SERIES 7000 AD TIBIAL TRAY	Osteonics Corp.	2000-04-06	535	0
K980070	OSTEONICS HA-COATED DEVICES	Osteonics Corp.	1999-07-23	561	0
K984375	OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY	Osteonics Corp.	1999-04-30	144	0
K982798	OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM	Osteonics Corp.	1999-03-25	227	0
K984585	OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE	Osteonics Corp.	1999-02-24	62	0
K990203	OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS	Osteonics Corp.	1999-02-18	28	0
K990158	OSTEONICS COMBINATION SCREW RING/BLOCKER	Osteonics Corp.	1999-02-01	13	0
K984302	OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS	Osteonics Corp.	1998-12-18	16	0
K984353	OSTEO 9MM IC TIBIAL NAIL	Osteonics Corp.	1998-12-16	9	0
K983502	OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SY	Osteonics Corp.	1998-12-16	71	0
K983382	OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM	Osteonics Corp.	1998-12-11	77	4
K983508	OSTEO COMPRESSION CONDYLE SCREW SYSTEM	Osteonics Corp.	1998-12-07	61	0
K983226	OSTEONICS X CEMENTED HIP STEM SERIES	Osteonics Corp.	1998-12-04	80	2
K983165	OSTEO 4.0MM CANNULATED SCREW SYSTEM	Osteonics Corp.	1998-12-03	84	0
K983870	OSTEONICS RESTORATION HA HIP STEMS	Osteonics Corp.	1998-12-02	30	0
K983339	OSTEO DYNATROC PROXIMAL FEMORAL NAIL	Osteonics Corp.	1998-10-27	34	0
K982936	OSTEONICS EXTENDED FEMORAL BEARING HEAD	Osteonics Corp.	1998-10-21	61	0
K983152	OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS	Osteonics Corp.	1998-09-25	16	0
K982553	OSTEO COMPRESSION HIP SCREW SYSTEM	Osteonics Corp.	1998-09-22	62	0
K974685	OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS	Osteonics Corp.	1998-09-22	280	0
K982601	OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL	Osteonics Corp.	1998-09-14	49	0
K982032	OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA	Osteonics Corp.	1998-07-09	29	1
K981309	OSTEO I-C HUMERAL NAIL SYSTEM	Osteonics Corp.	1998-06-22	73	0
K980766	OSTEONICS ANTEVERTED NECK HA HIP STEMS	Osteonics Corp.	1998-05-27	89	0
K981452	OSTEONICS LONG ARM CONTAINMENT RING	Osteonics Corp.	1998-05-20	28	0
K981259	OSTEO 4.0MM CANNULATED SCREW SYSTEM	Osteonics Corp.	1998-05-11	35	0
K980594	OSTEONICS FX-CABLELOK GRIP COMPONENTS	Osteonics Corp.	1998-05-05	77	0
K980502	OSTEONICS TOTAL ELBOW SYSTEM	Osteonics Corp.	1998-05-05	85	0
K980774	OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS	Osteonics Corp.	1998-04-29	58	0
K974807	OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM	Osteonics Corp.	1998-03-16	83	0
K974556	OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SY	Osteonics Corp.	1998-02-27	84	7
K972967	OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONE	Osteonics Corp.	1998-01-16	158	6
K974434	OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS	Osteonics Corp.	1998-01-12	49	0
K973438	OSTEO BOS SYSTEM PRODUCT LINE EXTENSION	Osteonics Corp.	1997-12-09	90	0
K973406	OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT	Osteonics Corp.	1997-12-08	90	0
K973204	OSTEO BOS SYSTEM IN STAINLESS STEEL	Osteonics Corp.	1997-09-25	30	0
K972460	OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)	Osteonics Corp.	1997-09-25	86	0
K972323	OSTEO BOS SYSTEM	Osteonics Corp.	1997-09-10	82	0
K972196	OSTEO ANATOMICAL BONE PLATES	Osteonics Corp.	1997-08-25	76	0
K971962	OSTEO KIRSCHNER WIRES	Osteonics Corp.	1997-08-11	75	0
K971800	OSTEO CANNULATED SCREW SYSTEM	Osteonics Corp.	1997-07-30	76	0
K971497	OSTEONICS ANTEVERTED NECK HIP STEM	Osteonics Corp.	1997-07-16	83	0
K971654	OSTEO COMPRESSION HIP SCREW SYSTEM	Osteonics Corp.	1997-07-09	64	0
K971409	OSTEONICS ALUMINA C-TAPER HEAD	Osteonics Corp.	1997-07-09	84	0
K971321	OSTEO COMPRESSION CONDYLE SCREW SYSTEM	Osteonics Corp.	1997-07-09	90	0
K971778	OSTEO SMALL AND MINI BONE SCREWS	Osteonics Corp.	1997-06-27	44	0
K970957	OSTEONICS RESTORATION ACETABULAR RING	Osteonics Corp.	1997-06-03	78	0
K971422	OSTEONICS ACETABULAR WEDGE SYSTEM	Osteonics Corp.	1997-05-22	35	0
K970779	OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS	Osteonics Corp.	1997-05-09	66	0
K970697	OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM	Osteonics Corp.	1997-04-24	58	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