Cleared Traditional

K941306 - FOUNDATION KNEE AUGMENTATION BLOCKS

K941306 is an FDA 510(k) clearance for FOUNDATION KNEE AUGMENTATION BLOCKS, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 328-day FDA review.

K941306 · Encore Orthopedics, Inc. · Orthopedic device
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Feb 1995
Decision
328d
Days
Class 2
Risk

K941306 is an FDA 510(k) clearance for the FOUNDATION KNEE AUGMENTATION BLOCKS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 328 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K941306

510(k) Number K941306 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 17, 1994
Decision Date February 08, 1995
Days to Decision 328 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
206d slower than avg
Panel avg: 122d · This submission: 328d
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 K941306.
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
K933494 · Exactech, Inc. · Mar 1995
EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
K932690 · Exactech, Inc. · Feb 1995
APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT
K934381 · Intermedics Orthopedics · Feb 1995
POSTERIOR STABILIZED APOLLO KNEE SYSTEM
K935789 · Intermedics Orthopedics · Feb 1995
KNEE PROTHESIS
K941769 · Joint Medical Products Corp. · Feb 1995
NEXT GENERATION KNEE SYSTEM
K933785 · Zimmer, Inc. · Jan 1995