Cleared Traditional

K881750 - NORMAL HUMERAL PROSTHESIS

K881750 is an FDA 510(k) clearance for NORMAL HUMERAL PROSTHESIS, manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K881750 · Osteonics Corp. · Orthopedic device
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Aug 1988
Decision
127d
Days
Class 2
Risk

K881750 is an FDA 510(k) clearance for the NORMAL HUMERAL PROSTHESIS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K881750

510(k) Number K881750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1988
Decision Date August 30, 1988
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWS Device Classification - Class 2, Special Controls

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 185
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K881750.
NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS
K895226 · 3M Company · Nov 1989
INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
K884943 · Intermedics Orthopedics · Apr 1989
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
K883816 · Osteonics Corp. · Nov 1988
INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP
K881836 · Intermedics Orthopedics · Aug 1988
FENLIN II SHOULDER PROSTHESIS
K870262 · Zimmer, Inc. · Apr 1987
OSTEONICS SHOULDER PROSTHESIS
K862535 · Osteonics Corp. · Sep 1986