Cleared Traditional

K930891 - SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST

K930891 is an FDA 510(k) clearance for SYNTHES (USA) UNIV SPINE ROD/SACRAL SCR..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 431-day FDA review.

K930891 · Synthes (Usa) · Orthopedic device
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Apr 1994
Decision
431d
Days
Class 2
Risk

K930891 is an FDA 510(k) clearance for the SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on April 29, 1994 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K930891

510(k) Number K930891 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 22, 1993
Decision Date April 29, 1994
Days to Decision 431 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
309d slower than avg
Panel avg: 122d · This submission: 431d
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 376
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K930891.
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994
TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON
K933205 · Danek Medical, Inc. · May 1994
LOW PROFILE MID CROSS BRACING
K931225 · Advanced Spine Fixation Systems, Inc. · May 1994
LOW PROFILE SLEAVE NUT ASSEMBLY
K931208 · Advanced Spine Fixation Systems, Inc. · Mar 1994
SENTRY POSTERIOR SPINAL SYSTEM
K930710 · Sofamor Danek Mfg., Inc. · Oct 1993
SELBY INSTRUMENTATION
K924474 · Advanced Spine Fixation Systems, Inc. · Sep 1993