Cleared Traditional

KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (K013982) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013982 · Kinamed, Inc. · Orthopedic device
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May 2002
Decision
169d
Days
Class 2
Risk

K013982 is an FDA 510(k) clearance for the KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT. Classified as Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer (product code KRR), Class II - Special Controls.

Submitted by Kinamed, Inc. (Camarillo, US). The FDA issued a Cleared decision on May 21, 2002 after a review of 169 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3540 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Kinamed, Inc. devices

Submission Details

510(k) Number K013982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date May 21, 2002
Days to Decision 169 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3540
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 - KRR Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer

All 14
Devices cleared under the same product code (KRR) and FDA review panel - the closest regulatory comparables to K013982.
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948 · Howmedica Osteonics Corp. · Oct 2005
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT
K051086 · Smith & Nephew, Inc. · May 2005
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT
K041160 · Howmedica Osteonics Corp. · May 2004
AVON PATELLAR COMPONENT
K020841 · Howmedica Osteonics Corp. · Apr 2002
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K010100 · Howmedica Osteonics Corp. · Apr 2001
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350 · Biomet, Inc. · Jul 2000