NATURAL-KNEE TIBIAL AND FEMORAL SPACERS— 510(k) K915240

Name: FDA 510(k) clearance K915240
Creator: U.S. Food and Drug Administration
Published: 1992-01-31

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K915240 for NATURAL-KNEE TIBIAL AND FEMORAL SPACERS, Substantially Equivalent on 1992-01-31. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code HSX
Device class: Class 2
Regulation: 21 CFR 888.3520
Advisory panel: Orthopedic
Date received: 1991-11-21
Decision date: 1992-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSX

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K261609 — Freedom Partial Knee System2026-08-04
K260796 — Tahoe Unicondylar Knee System with TiNbN Overcoat2026-04-02
K251771 — Cambridge Partial Knee2025-12-16
K251834 — Persona Partial Knee2025-08-15
K251618 — MOTO Partial Knee System Extension2025-07-24

More clearances from Intermedics Orthopedics

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K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI1997-07-03
K970498 — NATURAL-KNEE II REVISION FEMORAL SPACER LUGS1997-04-30
K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
K964357 — NATURAL-HIP SYSTEM COCR STEM1997-01-27

Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.