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510(k) K982963

POLYMER THREADED ANCHOR / SUTURE COMBINATION by Orthopaedic Biosystems, Ltd. — Product Code JDI

K982963 is an FDA 510(k) premarket notification submitted by Orthopaedic Biosystems, Ltd. for the device "POLYMER THREADED ANCHOR / SUTURE COMBINATION". The FDA issued a decision of Substantially Equivalent on November 20, 1998. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Orthopaedic Biosystems, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1998
Date Received
August 24, 1998
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 Orthopaedic Biosystems, Ltd.

  • K000797 — OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 (April 3, 2000)
  • K982996 — POLYMER OBL SB ANCHOR / SUTURE COMBINATION (March 4, 1999)
  • K983169 — POLYMER THREADED ANCHOR (December 16, 1998)
  • K972326 — PEBA ANCHOR/SUTURE COMBINATION (February 6, 1998)
  • K963420 — CANCELLOUS SCREW WASHER (November 15, 1996)
  • K963432 — GUIDE WIRES FOR CANNULATED SCREWS (November 13, 1996)
  • K963433 — THREADED FIXATION PIN (November 6, 1996)
  • K962779 — COMPRESSION SCREW (August 23, 1996)
  • K951451 — PEBA ANCHOR (MULTIPLE SIZES) (October 31, 1995)
  • K942889 — SB ANCHOR (August 25, 1995)

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