Atlas FDA

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

Biologically Oriented Prostheses — Predicate Candidate Screening

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

90 daysmedian FDA review time
223 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K002325WUJIN #3 TIBIAL NAILBiologically Oriented Prostheses2000-10-30900
K992144BIOPRO RIMMED ACETABULAR COMPOMENTBiologically Oriented Prostheses1999-09-22900
K964472RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENTBiologically Oriented Prostheses1997-02-03880
K962769HORIZON HIP SYSTEMBiologically Oriented Prostheses1996-10-03790
K955916TOWNLEY TOTAL ELBOW SYSTEMBiologically Oriented Prostheses1996-08-082230
K954768BIOPRO HEMI-ENDO MODULAR CERAMIC HEADBiologically Oriented Prostheses1996-01-18931
K952731TOWNLEY ALL POLY ACETABULAR CUPBiologically Oriented Prostheses1995-12-281960
K953045BIOPRO HEMI-ENDO MODULAR CERAMIC HEADBiologically Oriented Prostheses1995-09-27890
K951356VARIOUS UHMWP HIP & KNEE JOINT PROSTHESIS MODIFIEDBiologically Oriented Prostheses1995-06-19870

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