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

Protek, Inc. — Predicate Candidate Screening

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

85 daysmedian FDA review time
239 days90th percentile
25clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K893785ARC-2F ACETABULAR CUPProtek, Inc.1989-08-09790
K893959P.S.A. FEMORAL HIP PROSTHESISProtek, Inc.1989-07-25540
K892059FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SURProtek, Inc.1989-07-191120
K883794RESUBMITTED CLW ACETABULAR CUP W/SULMESHProtek, Inc.1989-05-262610
K884952VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMICProtek, Inc.1989-05-101620
K884889MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.Protek, Inc.1989-02-27970
K884789NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLIProtek, Inc.1989-02-08850
K890054M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.Protek, Inc.1989-02-08330
K884888MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWSProtek, Inc.1988-12-29370
K882671SAMUELSON SCREWLOC CUPProtek, Inc.1988-10-201140
K874093SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUPProtek, Inc.1988-01-271110
K870922C.L.E. ACETABULAR CUPProtek, Inc.1987-10-282390
K873429FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEEProtek, Inc.1987-10-28640
K872985SAMUELSON ACETABULAR CUPProtek, Inc.1987-10-01620
K870924CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.Protek, Inc.1987-09-141940
K870923SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.Protek, Inc.1987-09-141940
K872502M.W.P. WRIST PROSTHESISProtek, Inc.1987-07-23290
K871347WAGNER REVISIONAL FEMORAL HIP PROSTHESISProtek, Inc.1987-07-01861
K861988MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOYProtek, Inc.1987-02-112780
K862752C.S.M. HIPProtek, Inc.1986-08-07160
K853730FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REPProtek, Inc.1986-02-181650
K853768MULLER SELF LOCKING TOTAL HIPProtek, Inc.1985-11-19710
K853662MUELLER CURVED STEM HEMI-PROSTHESISProtek, Inc.1985-09-24210
K853267DAY STAPLEProtek, Inc.1985-09-06320
K853268FREEMAN UNI-COMPARTMENTAL KNEEProtek, Inc.1985-09-04300

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