Cleared Traditional

K881836 - INTERMEDICS SELECT SHOULDER ALL PLASTIC...

K881836 is an FDA 510(k) clearance for INTERMEDICS SELECT SHOULDER ALL PLASTIC..., manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code KWS cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K881836 · Intermedics Orthopedics · Orthopedic device
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Aug 1988
Decision
119d
Days
Class 2
Risk

K881836 is an FDA 510(k) clearance for the INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on August 29, 1988 after a review of 119 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K881836

510(k) Number K881836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1988
Decision Date August 29, 1988
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
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 153
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K881836.
INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
K884943 · Intermedics Orthopedics · Apr 1989
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
K883816 · Osteonics Corp. · Nov 1988
NORMAL HUMERAL PROSTHESIS
K881750 · Osteonics Corp. · Aug 1988
FENLIN II SHOULDER PROSTHESIS
K870262 · Zimmer, Inc. · Apr 1987
OSTEONICS SHOULDER PROSTHESIS
K862535 · Osteonics Corp. · Sep 1986
COFIELD SHOULDER SYSTEM
K855183 · Richards Medical Co., Inc. · Mar 1986