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

HXA — Predicate Candidate Screening

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

88 daysmedian FDA review time

144 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K243477	Universal Tendon Spacer	Askorn Medical	2025-01-10	63
K000019	SINGLE SIZE TENDON SPACER	Medist International	2000-03-29	85
K973385	OVAL SHAPES	Technical Products, Inc.	1997-12-05	88
K964359	AVANTA ORTHOPAEDICS TENDON SPACER	Avanta Orthopaedics, Inc.	1997-03-25	144
K930125	PHOENIX BONE SCREWS PBS-TYPE SERIES	Phoenix Bioengineering, Inc.	1993-12-30	352
K872285	H-H HUNTER ACTIVE TENDON IMPLANT DC	Holter-Hausner Intl.	1987-09-28	104
K872293	H-H HUNTER ACTIVE TENDON IMPLANT BC	Holter-Hausner Intl.	1987-09-28	104
K872284	H-H HUNTER ACTIVE TENDON IMPLANT PC	Holter-Hausner Intl.	1987-09-28	104
K853438	H-H HUNTER ACTIVE TENDON IMPLANT	Holter-Hausner Intl.	1985-09-30	46
K781943	TENDON ROD MODEL OR41PO3-6	Holter-Hausner Intl.	1978-12-04	17
K780320	PASSIVE TENDON IMPLANT	Holter-Hausner Intl.	1978-03-17	21

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