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510(k) K941769

KNEE PROTHESIS by Joint Medical Products Corp. — Product Code JWH

K941769 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "KNEE PROTHESIS". The FDA issued a decision of SN on February 1, 1995. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Joint Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
February 1, 1995
Date Received
April 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Joint Medical Products Corp.

  • K955511 — ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP (February 26, 1996)
  • K954935 — S-ROM FEMORAL HIP STEM - SIZE 14 X 8 (January 22, 1996)
  • K944321 — S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II (August 14, 1995)
  • K951726 — S-ROM ZTP UHMWPE ACETABULAR CUP (June 21, 1995)
  • K951084 — S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS (May 31, 1995)
  • K951000 — ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM (April 14, 1995)
  • K936037 — S-ROM NOILES CRUCIATE RETAINING KNEE (October 3, 1994)
  • K934412 — COATED ZT PROXIMAL SLEEVE (June 3, 1994)
  • K931676 — S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG (May 18, 1994)
  • K935078 — S-ROM TOTAL HIP REPLACEMENT SYSTEM (March 9, 1994)

Other clearances for product code JWH

  • K261458 — ATTUNE Total Knee System; ATTUNE Cementless Knee System (June 25, 2026)
  • K261032 — NovoKnee (SteriKnee) (April 27, 2026)
  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)

FDA data resources