Cleared Traditional

K955710 - J.B.S. T.T.A SCREW

K955710 is an FDA 510(k) clearance for J.B.S. T.T.A SCREW, manufactured by J.B.S. (Usa), Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K955710 · J.B.S. (Usa), Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
81d
Days
Class 2
Risk

K955710 is an FDA 510(k) clearance for the J.B.S. T.T.A SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by J.B.S. (Usa), Inc. (Mill Valley, US). The FDA issued a Cleared decision on March 4, 1996 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 J.B.S. (Usa), Inc. devices

FDA 510(k) Submission Details - K955710

510(k) Number K955710 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 14, 1995
Decision Date March 04, 1996
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 920
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K955710.
K3 BONE SCREW SYSTEM
K960533 · Kinetikos Medical, Inc. · Mar 1996
K2 BONE SCREW SYSTEM
K960537 · Kinetikos Medical, Inc. · Mar 1996
NORTHO BONE SCREW
K925872 · Northo Orthopedics · Mar 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837 · Wrightmedicaltechnologyinc · Mar 1996
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · Acufex Microsurgical, Inc. · Feb 1996
MLI INTERFERENCE SCREW
K953350 · Medicinelodge, Inc. · Jan 1996