Cleared Traditional

K881289 - CORIN BIPOLAR PROSTHESIS

K881289 is an FDA 510(k) clearance for CORIN BIPOLAR PROSTHESIS, manufactured by Orthopedic Systems, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K881289 · Orthopedic Systems, Inc. · Orthopedic device
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Jun 1988
Decision
93d
Days
Class 2
Risk

K881289 is an FDA 510(k) clearance for the CORIN BIPOLAR PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on June 29, 1988 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 Orthopedic Systems, Inc. devices

FDA 510(k) Submission Details - K881289

510(k) Number K881289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1988
Decision Date June 29, 1988
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 76
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K881289.
VS22 HIP PROSTHESIS
K896266 · 3M Company · Nov 1989
P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT
K893872 · Johnson & Johnson Professionals, Inc. · Sep 1989
ZIMMER BEADED THREADED ACETABULAR CUP
K884658 · Zimmer, Inc. · Nov 1988
IOI BIPOLAR PROSTHESIS
K873815 · Intermedics Orthopedics · Oct 1987
JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS
K873514 · Johnson & Johnson Professionals, Inc. · Sep 1987
BI-ARTICULAR II HIP DEVICE
K872019 · Zimmer, Inc. · Jul 1987