Cleared Traditional

K936159 - NATURAL-KNEE II SYSTEM

K936159 is an FDA 510(k) clearance for NATURAL-KNEE II SYSTEM, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 515-day FDA review.

K936159 · Intermedics Orthopedics · Orthopedic device
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May 1995
Decision
515d
Days
Class 2
Risk

K936159 is an FDA 510(k) clearance for the NATURAL-KNEE II SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Intermedics Orthopedics devices

FDA 510(k) Submission Details - K936159

510(k) Number K936159 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 23, 1993
Decision Date May 22, 1995
Days to Decision 515 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
393d slower than avg
Panel avg: 122d · This submission: 515d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K936159.
CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
K946150 · Zimmer, Inc. · Jul 1995
DURACON RECESSED PATELLA
K951655 · Howmedica Corp. · Jul 1995
NATURAL-KNEE(R)/APOLLO(TM) KNEE
K935523 · Intermedics Orthopedics · Jun 1995
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
K950010 · Johnson & Johnson Professionals, Inc. · May 1995
DURACON STABILIZER FEMORAL COMPONENT AND INSERT
K932070 · Howmedica Corp. · Mar 1995
ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE
K945087 · Wrightmedicaltechnologyinc · Mar 1995