Cleared Traditional

K961260 - KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY

K961260 is an FDA 510(k) clearance for KIRSCHNER SHOLDERS WITH TITANIUM PLASMA..., manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K961260 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1997
Decision
365d
Days
Class 2
Risk

K961260 is an FDA 510(k) clearance for the KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K961260

510(k) Number K961260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1996
Decision Date April 02, 1997
Days to Decision 365 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 122d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSD Device Classification - Class 2, Special Controls

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 66
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K961260.
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HOWMEDICA HUMERAL INTERCALARY SYSTEM
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OTI MODULAR SHOULDER SYSTEM
K982886 · Osteoimplant Technology, Inc. · Oct 1998
SELECT SHOULDER COCR HUMERAL STEM COMPONENT
K962289 · Intermedics Orthopedics · Aug 1996
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
K954559 · Howmedica Corp. · Jul 1996
INFINITY SHOULDER SYSTEM
K943908 · Wrightmedicaltechnologyinc · May 1995