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510(k) K934412

COATED ZT PROXIMAL SLEEVE by Joint Medical Products Corp. — Product Code LPH

K934412 is an FDA 510(k) premarket notification submitted by Joint Medical Products Corp. for the device "COATED ZT PROXIMAL SLEEVE". The FDA issued a decision of Substantially Equivalent on June 3, 1994. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Joint Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1994
Date Received
September 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
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)
  • K941769 — KNEE PROTHESIS (February 1, 1995)
  • K936037 — S-ROM NOILES CRUCIATE RETAINING KNEE (October 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 LPH

  • K261624 — Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrain (July 10, 2026)
  • K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed C (June 5, 2026)
  • K251270 — Taperloc® Complete Hip Stem (May 19, 2026)
  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)

FDA data resources