Home / 510(k) Clearances / K951084

510(k) K951084

S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS by Joint Medical Products Corp. — Product Code JDI

K951084 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS". The FDA issued a decision of Substantially Equivalent on May 31, 1995. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Joint Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1995
Date Received
March 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
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)
  • K951000 — ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM (April 14, 1995)
  • K941769 — KNEE PROTHESIS (February 1, 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 JDI

  • K253434 — OSSTM Orthopedic Salvage System (July 1, 2026)
  • K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (March 12, 2026)
  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)

FDA data resources