Atlas FDA

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

Encore Medical L.P. · Predicate Candidate Screening

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

93 daysmedian FDA review time
259 days90th percentile
81clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.2026-01-151540
K252974EMPOWR KneeEncore Medical L.P.2025-12-19930
K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.2025-11-121490
K252141AltiVate Reverse® GlenoidEncore Medical L.P.2025-08-05280
K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial InserEncore Medical L.P.2025-07-08280
K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT CoEncore Medical L.P.2025-07-02710
K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR SEncore Medical L.P.2025-05-16300
K241483ceramys™ femoral head systemEncore Medical L.P.2025-02-072590
K233481AltiVate Reverse® GlenoidEncore Medical L.P.2024-05-292168
K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.2023-06-233010
K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.2022-07-072660
K213793EMPOWR Revision KneeEncore Medical L.P.2022-04-011160
K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.2021-03-30550
K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Encore Medical L.P.2021-02-10652
K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.2020-12-23820
K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.2020-06-031940
K191325EMPOWR Partial KneeEncore Medical L.P.2019-07-16610
K190057DJO Acetabular SystemEncore Medical L.P.2019-06-071473
K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.2019-04-26740
K180930EMPOWR VVC TIBIAL INSERTEncore Medical L.P.2018-07-09901
K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.2018-03-05901
K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.2017-12-26880
K172651FMP Extended LinersEncore Medical L.P.2017-12-13990
K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small SpacerEncore Medical L.P.2017-10-30882
K171991EMPOWR Porous Knee SystemEncore Medical L.P.2017-10-04933
K170573Empowr CR Knee Tibial InsertEncore Medical L.P.2017-05-31930
K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Encore Medical L.P.2017-03-02790
K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016-11-211220
K161610EXPRT Revision Hip SystemEncore Medical L.P.2016-11-091520
K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision KneEncore Medical L.P.2016-09-23700
K160342EMPOWR PS Knee SystemEncore Medical L.P.2016-05-191011
K143242Rebel 3DKNEE SystemEncore Medical L.P.2015-05-1518412
K141990ENCORE HUMERAL SHOULDER STEMEncore Medical L.P.2014-11-071083
K140130X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, Encore Medical L.P.2014-11-062930
K140830EXPRT REVISION KNEEEncore Medical L.P.2014-07-111001
K140904RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6Encore Medical L.P.2014-05-06270
K130550RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINEncore Medical L.P.2014-03-243850
K130048REVERSE SHOULDER PROSTHESIS MONOBLOCKEncore Medical L.P.2013-10-292940
K130365X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINEREncore Medical L.P.2013-09-232220
K130099TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019Encore Medical L.P.2013-06-211570
K122239FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEEEncore Medical L.P.2013-04-112580
K123982TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+Encore Medical L.P.2013-01-23280
K122636REVELATION POROUS COATED HIP STEM, SIZE 8Encore Medical L.P.2012-11-02650
K121727MOVATION KNEE SYSTEMEncore Medical L.P.2012-08-15640
K121835DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATEncore Medical L.P.2012-07-20280
K121024LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, Encore Medical L.P.2012-06-19760
K113756HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKEncore Medical L.P.2012-03-14841
K120241LINEAR HIP STEM, SIZE 5Encore Medical L.P.2012-02-24280
K112069RSP GLENOID BASEPLATE POROUS COATEDEncore Medical L.P.2011-11-151181
K111735REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTEREncore Medical L.P.2011-10-031040

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