Cleared Traditional

K955778 - NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM

K955778 is an FDA 510(k) clearance for NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K955778 · Intermedics Orthopedics · Orthopedic device
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Mar 1996
Decision
79d
Days
Class 2
Risk

K955778 is an FDA 510(k) clearance for the NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on March 8, 1996 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics Orthopedics devices

FDA 510(k) Submission Details - K955778

510(k) Number K955778 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 20, 1995
Decision Date March 08, 1996
Days to Decision 79 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K955778.
P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
K954481 · Johnson & Johnson Professionals, Inc. · Oct 1996
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
K961900 · Wrightmedicaltechnologyinc · Jul 1996
ADVANCE TIBIAL COMPONENT
K960617 · Wrightmedicaltechnologyinc · May 1996
GAS PLASMA STERILIZATION
K944538 · Depuy, Inc. · Sep 1995
CKS POROUS COATED FEMORAL COMPONENT
K933935 · Techmedica, Inc. · Oct 1994
OSTEONICS UNIX UNICOMPARTMENTAL
K923011 · Osteonics Corp. · Nov 1993