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

Encore Orthopedics, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time
338 days90th percentile
85clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K0329053DKNEE POROUS COATED FEMORAL COMPONENTEncore Orthopedics, Inc.2004-07-062930
K0201143D KNEEEncore Orthopedics, Inc.2002-07-121825
K020741UNICONDYLAR KNEEEncore Orthopedics, Inc.2002-06-04902
K020236MODIFICATION TO PASS SPINAL SYSTEMEncore Orthopedics, Inc.2002-02-14220
K020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPEncore Orthopedics, Inc.2002-02-11250
K013490CEMENTED CALCAR HIP SYSTEMEncore Orthopedics, Inc.2002-01-17870
K013442PASS SPINAL SYSTEMEncore Orthopedics, Inc.2002-01-15900
K003324PLASMA SPRAYED SHOULDEREncore Orthopedics, Inc.2001-12-064080
K013431PASS SPINAL SYSTEMEncore Orthopedics, Inc.2001-11-15300
K013191PASS SPINAL SYSTEMEncore Orthopedics, Inc.2001-10-24300
K011856RADIOGRAPHIC MARKERSEncore Orthopedics, Inc.2001-08-22700
K012175PASS SPINAL SYSTEMEncore Orthopedics, Inc.2001-07-31190
K003250FMP METAL/METAL ACETABULAR INSERTEncore Orthopedics, Inc.2001-01-251000
K002941ACETABULAR PLATESEncore Orthopedics, Inc.2000-12-04740
K002959MODIFICATION TO ISOBAR SPINAL SYSTEMEncore Orthopedics, Inc.2000-10-16240
K001847ANTERIOR CERVICAL PLATE SYSTEMEncore Orthopedics, Inc.2000-08-24660
K001024PASS SPINAL SYSTEMEncore Orthopedics, Inc.2000-05-23540
K000590LATERAL PIVOT INSERTEncore Orthopedics, Inc.2000-05-11800
K000521KEYSTONE HIPEncore Orthopedics, Inc.2000-05-10840
K993841CEMSTOP CEMENT RESTRICTOREncore Orthopedics, Inc.2000-05-041740
K993630BIOLOK SCREWEncore Orthopedics, Inc.2000-04-261820
K000425ISOBAR SPINAL SYSTEMEncore Orthopedics, Inc.2000-03-07270
K993943ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION PEncore Orthopedics, Inc.2000-02-04771
K000020MODIFICATION TO ISOBAR SPINAL SYSTEMEncore Orthopedics, Inc.2000-02-03300
K994070REVELATION POROUS HIP STEMEncore Orthopedics, Inc.2000-01-20490
K992738ISOBAR SPINAL SYSTEMEncore Orthopedics, Inc.1999-11-08870
K992109ENCORE FULLY COATED HIPEncore Orthopedics, Inc.1999-08-12510
K991889ULTIMAX HAIG II NAIL SYSTEMEncore Orthopedics, Inc.1999-08-12700
K991790ULTIMAX ANKLE FUSION ROD SYSTEMEncore Orthopedics, Inc.1999-08-06720
K991603GRIT BLASTED HUMERAL STEMEncore Orthopedics, Inc.1999-06-29500
K991325MODIFICATION OF ENCORE LINEAR POROUS COATED HIPEncore Orthopedics, Inc.1999-06-25670
K9912278MM FORGED CEMENTED STEMEncore Orthopedics, Inc.1999-06-01500
K991226FOUNDATION POROUS HIP STEMEncore Orthopedics, Inc.1999-06-01500
K982160HINGED KNEEEncore Orthopedics, Inc.1999-03-172710
K982663STIMULAN- CALCIUM SULFATE BONE VOID FILLEREncore Orthopedics, Inc.1999-02-262110
K980854RETROGRADE PEDIATRIC NAILEncore Orthopedics, Inc.1998-08-111590
K980473PRESS-FIT STEMEncore Orthopedics, Inc.1998-04-16690
K974095FOUNDATION POROUS COATED FLARED RIM SHELLEncore Orthopedics, Inc.1998-01-28900
K973119FOUNDATION POROUS ACETABULAR SYSTEMEncore Orthopedics, Inc.1998-01-281610
K974093FOUNDATION POROUS COATED HEMISPHERICAL SHELLEncore Orthopedics, Inc.1998-01-28900
K972791ENCORE LINEAR HIPEncore Orthopedics, Inc.1998-01-121680
K974294ENCORE LINEAR POROUS COATED HIPEncore Orthopedics, Inc.1998-01-12591
K973809FOUNDATION FRACTURE STEMEncore Orthopedics, Inc.1998-01-02880
K973685REVELATION POROUS HIP STEMEncore Orthopedics, Inc.1997-12-19840
K973614FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEncore Orthopedics, Inc.1997-12-18860
K973672FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLAEncore Orthopedics, Inc.1997-12-18830
K973302FOUNDATION POROUS HIP STEMEncore Orthopedics, Inc.1997-12-02900
K965002ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTUEncore Orthopedics, Inc.1997-06-271930
K964178PRESS-FIT HIP STEMEncore Orthopedics, Inc.1997-05-051990
K970031FOUNDATION KNEE SYSTEM TIBIAL COMPONENTEncore Orthopedics, Inc.1997-04-02892

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