Cleared Traditional

K933205 - TSRH TOP TIGHT T-BOLT-VARI ANGLE/SCREW/...

K933205 is an FDA 510(k) clearance for TSRH TOP TIGHT T-BOLT-VARI ANGLE/SCREW/..., manufactured by Danek Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K933205 · Danek Medical, Inc. · Orthopedic device
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May 1994
Decision
307d
Days
Class 2
Risk

K933205 is an FDA 510(k) clearance for the TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Danek Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 307 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: 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 Danek Medical, Inc. devices

FDA 510(k) Submission Details - K933205

510(k) Number K933205 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 01, 1993
Decision Date May 04, 1994
Days to Decision 307 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
185d slower than avg
Panel avg: 122d · This submission: 307d
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 309
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K933205.
STRYKER 2S SPINAL SYSTEM
K930009 · Stryker Corp. · Sep 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
TI-FRAME
K934860 · Johnson & Johnson Professionals, Inc. · Jun 1994
SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST
K930891 · Synthes (Usa) · Apr 1994
COTREL - DUBOUSSET SPINE IMPLANTS
K921056 · Buckman Co., Inc. · Jun 1993
COMPACT COTREL -- DUBOUSSET SPINE SYSTEM
K921767 · Buckman Co., Inc. · Jun 1993