Cleared Traditional

K890044 - BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE

K890044 is an FDA 510(k) clearance for BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE, manufactured by Biopro, Inc.. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K890044 · Biopro, Inc. · Orthopedic device
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Nov 1989
Decision
305d
Days
Class 2
Risk

K890044 is an FDA 510(k) clearance for the BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Biopro, Inc. (Port Huron, US). The FDA issued a Cleared decision on November 6, 1989 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Biopro, Inc. devices

FDA 510(k) Submission Details - K890044

510(k) Number K890044 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 05, 1989
Decision Date November 06, 1989
Days to Decision 305 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
183d slower than avg
Panel avg: 122d · This submission: 305d
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 84
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K890044.
P.F.C. UNICONDYLAR KNEE SYSTEM
K910968 · Johnson & Johnson Orthopaedics, Inc. · Aug 1991
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
K911373 · Osteonics Corp. · Jun 1991
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
K902538 · Dow Corning Wright · Jul 1990
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969 · Intermedics Orthopedics · Apr 1989
KINEMAX TIBIAL WEDGE
K884837 · Howmedica Corp. · Feb 1989
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241 · Kirschner Medical Corp. · Jun 1988