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

Orthomet, Inc. · Predicate Candidate Screening

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

93 daysmedian FDA review time
499 days90th percentile
60clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K936310ORTHOMET HMC FEMORAL STEM COMPONENTOrthomet, Inc.1995-06-074260
K945783ORTHOMET TITANIUM HYBRID FEMORAL STEMOrthomet, Inc.1995-05-301860
K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.1995-04-262600
K944752ORTHOMET RESURFACING FEMORAL COMPONENTOrthomet, Inc.1994-12-28930
K930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMOrthomet, Inc.1994-11-306520
K926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSEROrthomet, Inc.1994-10-186710
K932677AXIOM TOTAL KNEE SYSTEMOrthomet, Inc.1994-10-144990
K931678ORTHOMET LHMC FEMORAL STEMOrthomet, Inc.1994-10-145560
K931333ORTHOMET ACETABULAR CUP SYSTEMOrthomet, Inc.1994-10-145770
K923243PERFECTA TOTAL HIP SYSTEMOrthomet, Inc.1994-01-075540
K925536HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEMOrthomet, Inc.1994-01-074310
K924698AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAYOrthomet, Inc.1993-10-274050
K930595AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAYOrthomet, Inc.1993-10-222590
K924050TITANIUM NITRIDE COATED HEMI-HEAD COMPONENTOrthomet, Inc.1993-08-253850
K922847PERFECTA TOTAL HIP SYSTEMOrthomet, Inc.1993-04-062950
K922733PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIPOrthomet, Inc.1993-02-092460
K915190PERFECTA TOTAL HIP SYSTEM, HA COATEDOrthomet, Inc.1992-12-243980
K923583ORTHOMET PERFECTA TOTAL HIP SYSTEMOrthomet, Inc.1992-12-071400
K921836PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEADOrthomet, Inc.1992-11-062030
K923909CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTALOrthomet, Inc.1992-11-04920
K922734AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEMOrthomet, Inc.1992-09-10940
K920698FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTSOrthomet, Inc.1992-08-031820
K920426PSK FEMORAL AND TIBIAL INSERT COMPONENTOrthomet, Inc.1992-08-031820
K915868PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENTOrthomet, Inc.1992-03-23840
K915795PERFECTA PDA TOTAL HIP SYSTEMOrthomet, Inc.1992-03-04650
K914230AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAYOrthomet, Inc.1991-12-16870
K912894AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERTOrthomet, Inc.1991-10-181090
K911198TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SYOrthomet, Inc.1991-05-23660
K911197PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEMOrthomet, Inc.1991-05-23660
K903635PERFECTA TOTAL HIP SYSTEMOrthomet, Inc.1990-11-09880
K895145SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAROrthomet, Inc.1990-07-063220
K901936PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMPOrthomet, Inc.1990-07-03640
K902259AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENTOrthomet, Inc.1990-06-18280
K901328DOMED AND FINNED ACETABULAR COMPONENTOrthomet, Inc.1990-05-22620
K893040ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEGOrthomet, Inc.1989-11-202100
K894334SECOND GENERATION KNEE SYSTEMOrthomet, Inc.1989-10-06840
K893762PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENTOrthomet, Inc.1989-09-151190
K892398BIPOLAR HIP SYSTEMOrthomet, Inc.1989-05-23460
K890742INTRAFORM TOTAL HIP SYSTEMOrthomet, Inc.1989-05-10860
K884027PERFECTA II/NON-COATED TOTAL HIP SYSTEMOrthomet, Inc.1989-04-071960
K884585LEA PLAZA SPINAL FRAME SYSTEMOrthomet, Inc.1989-01-27860
K883618PERFECTA II TOTAL HIP SYSTEMOrthomet, Inc.1988-12-281260
K883941PROFORMA HIP SYSTEMOrthomet, Inc.1988-11-30720
K880435PROFORMA/PS TOTAL HIP SYSTEMOrthomet, Inc.1988-06-291480
K880390INTRAFORM TOTAL HIP SYSTEMOrthomet, Inc.1988-04-05670
K880461PERFECTA TOTAL HIP SYSTEMOrthomet, Inc.1988-03-15410
K880004TOWNLEY COX COMB ACETABULAR CUPOrthomet, Inc.1988-02-18450
K875201PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEGOrthomet, Inc.1988-02-17610
K874914ORTHOMET ORTHOPEDIC STAPLESOrthomet, Inc.1988-02-04630
K874915ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESISOrthomet, Inc.1988-02-03620

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