Cleared Traditional

K851935 - EDWARDS SACRAL SCREW

K851935 is an FDA 510(k) clearance for EDWARDS SACRAL SCREW, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K851935 · Zimmer, Inc. · Orthopedic device
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Jun 1985
Decision
32d
Days
Class 2
Risk

K851935 is an FDA 510(k) clearance for the EDWARDS SACRAL SCREW. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 7, 1985 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K851935

510(k) Number K851935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1985
Decision Date June 07, 1985
Days to Decision 32 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
90d faster than avg
Panel avg: 122d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWP Device Classification - Class 2, Special Controls

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 282
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K851935.
LUMBAR IMPACTION SET
K875290 · T. Korossurgical Instruments Corp. · Mar 1988
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K874882 · Acromed Corp. · Feb 1988
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524 · Kirschner Medical Corp. · Dec 1985
DEPUY SEGMENTALSPINAL SYSTEM
K810329 · Depuy, Inc. · Apr 1981
ARMSTRONG SPINAL APPLIANCE
K810224 · Howmedica Corp. · Feb 1981
SYNTHES SPINAL IMPLANT SYSTEM
K802462 · Synthes (Usa) · Dec 1980