Atlas FDA

EMPOWR Stem Extender, 50mm

FDA 510(k) clearance K230441 · decided 2023-03-17

Clearance details

K-number
K230441
Device name
EMPOWR Stem Extender, 50mm
Applicant
Encore Medical, L.P Dba Enovis
Decision
Substantially Equivalent
Date received
2023-02-21
Decision date
2023-03-17
Days to decision
24 days
Clearance type
Special
Product code
JWH
Device class
2
Regulation number
888.3560
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Austin, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Freedom Total Knee System (E-Poly Tibial Liners) (K261563)Maxx Orthopedics, Inc.2026-08-07
ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (K262251)Globus Medical, Inc.2026-07-31
Klassic Infection Spacer System (K261734)Total Joint Orthopedics, Inc.2026-07-23
ATTUNE Total Knee System; ATTUNE Cementless Knee System (K261458)DePuy Ireland UC2026-06-25
NovoKnee (SteriKnee) (K261032)NovoSource2026-04-27
Materialise TKA Guide System (K253793)Materialise NV2026-01-06
EMPOWR Knee (K252974)Encore Medical L.P.2025-12-19
ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (K253197)Depuy Ireland UC2025-11-19
Freedom Infinia™ Total Knee System (K253314)Maxx Orthopedics, Inc.2025-10-29
Freedom® Total Knee System – Titan PCK Components (K253144)Maxx Orthopedics, Inc.2025-10-22
Stem Extension Line (U2 Total Knee System—PSA Type) (K252725)United Orthopedic Corporation2025-09-25
Materialise TKA Guide System (K251554)Materialise NV2025-07-14

Recalls involving this device

No recalls on record reference this clearance.