Cleared Traditional

K935113 - J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE

K935113 is an FDA 510(k) clearance for J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE, manufactured by J.B.S., S.A.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K935113 · J.B.S., S.A. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
359d
Days
Class 2
Risk

K935113 is an FDA 510(k) clearance for the J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by J.B.S., S.A. (Foster City, US). The FDA issued a Cleared decision on October 19, 1994 after a review of 359 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.

FDA 510(k) Submission Details - K935113

510(k) Number K935113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1993
Decision Date October 19, 1994
Days to Decision 359 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
237d slower than avg
Panel avg: 122d · This submission: 359d
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 429
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K935113.
BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
K945435 · Arcan Orthopaedic Corp. · May 1995
APOFIX CERVICAL SPINE FIXATION
K945022 · Sofamor Co. · May 1995
AME UNIVERSAL FIXATION SYSTEM
K931381 · American Medical Electronics, Inc. · Feb 1995
STRYKER 2S SPINAL SYSTEM
K930009 · Stryker Corp. · Sep 1994
DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM
K933881 · Depuy, Inc. · Jul 1994
ALPHA SPINAL SYSTEM
K930515 · Alphatec Mfg., Inc. · Jun 1994
K935113 · J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE
Download PDF FDA Summary J.B.S., S.A.