Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KTW — Predicate Candidate Screening

38 FDA 510(k) clearances under this product code; the 50 most recent screened below.

65 daysmedian FDA review time

301 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K182285	PK High Tibial Osteotomy Correction System	Paonan Biotech Co., Ltd.	2019-06-20	301	0
K171606	AOS Anterolateral Proximal Humeral Plate	Advanced Orthopaedic Solutions, Inc. (Aos)	2017-06-22	21	0
K170693	Phantom Small Bone Intramedullary Nail System	Paragon 28, Inc.	2017-06-19	104	0
K160409	AOS Anterolateral Proximal Humeral Plate	Advanced Orthopaedic Solutions, Inc.	2016-03-15	28	0
K122541	ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)	Orthofix Srl	2012-09-20	30	0
K080590	AOS PROXIMAL HUMERAL PLATE	Advanced Orthopaedic Solutions, Inc.	2008-05-06	64	0
K080109	SYNTHES (USA) MODULAR BLADE PLATE SYSTEM	Synthes (Usa)	2008-03-20	65	56
K062920	ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP	Orthofix Srl	2006-11-13	46	0
K023360	LEFORTE SYSTEM BONE PLATE	Jeil Medical Corporation	2002-10-25	18	0
K012645	REPROCESSED EBI EXTERNAL FIXATION DEVICES	Alliance Medical Corp.	2002-06-24	315	0
K012634	REPROCESSED EXTERNAL FIXATION DEVICE	Alliance Medical, Inc.	2002-06-24	315	0
K011815	SYNTHES LCP PROXIMAL HUMERUS PLATES	Synthes (Usa)	2001-09-06	87	0
K011458	SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM	Synthes (Usa)	2001-08-02	83	0
K010321	MODULAR FOOT SYSTEM - 2.7 MM MODULE	Synthes (Usa)	2001-05-02	89	0
K001614	STRYKER TRAUMA PELVIC SET	Howmedica Osteonics Corp.	2000-08-04	71	0
K001271	SAMARCO SPIDER PLATES	Biomet, Inc.	2000-07-14	85	0
K992837	3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3	Synthes (Usa)	1999-10-25	63	0
K991405	OMNI-FIX, HUMERAL NAIL	Turnkey Intergration USA, Inc.	1999-06-29	68	0
K990307	OMNI-FIX, NAIL SYSTEM	Turnkey Intergration USA, Inc.	1999-04-01	59	0
K982390	CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)	Wrightmedicaltechnologyinc	1998-09-14	67	0
K971272	TRAUMA-FIX EXTERNAL FIXATOR	Trend Medical, Inc.	1997-06-05	62	0
K954289	SYNTHES CANNULATED ANGLE BLADE PLATE	Synthes (Usa)	1995-11-24	71	0
K931686	MALLEOLAR SCREW	Onyx Medical Corp.	1994-04-05	365	0
K925635	TORUS EXTERNAL FIXATION SYSTEM	Zimmer, Inc.	1993-06-01	204	0
K924657	TRUE/FLEX METATARSAL RODS	Applied Osteo Systems, Inc.	1992-11-24	70	0
K914546	ANGLED BLADE PLATE	Synthes (Usa)	1991-11-29	49	0
K905348	HANSEN-STREET TYPE INTRAMEDULLARY NAIL	O'Tec Corp.	1990-12-11	13	0
K893928	LEVTECH SMALL BONE PLATE	Buckman Co., Inc.	1989-11-03	156	0
K870727	WARSAW ORTHOPEDIC I BONE PLATE	Warsaw Orthopedic, Inc.	1987-03-09	13	0
K862552	ACROMED ADS BONE NAIL	Buckman Co., Inc.	1986-09-02	61	0
K862279	EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM	Orthospec, Inc.	1986-07-25	39	0
K851349	LERE NAIL & PLATE COMBIN. ONE PIECE FORGED	Medicalex	1985-05-29	55	0
K843554	BONE SCREWS	Mecron Medical Products, Inc.	1984-10-01	21	0
K843553	BONE PLATES	Mecron Medical Products, Inc.	1984-10-01	21	0
K821566	ORTHOPEDIC FIXATION DEVICES	Howmedica Corp.	1982-06-03	9	0
K813340	HIP PIN	The Deca Co.	1982-01-29	65	0
K792291	SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES	Synthes (Usa)	1979-12-06	23	0
K781762	COMPRESSION HIP SCREW SYSTEM	Howmedica Corp.	1978-12-20	65	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