Cleared Traditional

K922865 - NEER TYPE SHOULDER PROSTHESIS SYSTEM

K922865 is an FDA 510(k) clearance for NEER TYPE SHOULDER PROSTHESIS SYSTEM, manufactured by Osteo Technology, Inc.. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K922865 · Osteo Technology, Inc. · Orthopedic device
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Dec 1992
Decision
189d
Days
Class 2
Risk

K922865 is an FDA 510(k) clearance for the NEER TYPE SHOULDER PROSTHESIS SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on December 10, 1992 after a review of 189 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 Osteo Technology, Inc. devices

FDA 510(k) Submission Details - K922865

510(k) Number K922865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date December 10, 1992
Days to Decision 189 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 61
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K922865.
KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
K940537 · Kirschner Medical Corp. · Aug 1995
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · Biomet, Inc. · Oct 1994
SELECT(R) SHOULDER ALL-POLY GLENOID
K931114 · Intermedics Orthopedics · May 1994
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · Biomet, Inc. · Mar 1992
GLOBAL TOTAL SHOULDER
K914695 · Depuy, Inc. · Jan 1992
GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE
K914000 · Depuy, Inc. · Dec 1991