Atlas FDA

EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert

FDA 510(k) clearance K230169 · decided 2023-04-06

Clearance details

K-number
K230169
Device name
EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert
Applicant
Encore Medical, L.P Dba Enovis
Decision
Substantially Equivalent
Date received
2023-01-20
Decision date
2023-04-06
Days to decision
76 days
Clearance type
Traditional
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

+ Add to Predicate Builder ◉ Watch Encore Medical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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.