Cleared Traditional

K980788 - ALPHATEC WIRE EXTERNAL FIXATION SYSTEM

K980788 is an FDA 510(k) clearance for ALPHATEC WIRE EXTERNAL FIXATION SYSTEM, manufactured by Alphatec Mfg., Inc.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K980788 · Alphatec Mfg., Inc. · Orthopedic device
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May 1998
Decision
81d
Days
Class 2
Risk

K980788 is an FDA 510(k) clearance for the ALPHATEC WIRE EXTERNAL FIXATION SYSTEM. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Alphatec Mfg., Inc. (Palm Desert, US). The FDA issued a Cleared decision on May 22, 1998 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 Alphatec Mfg., Inc. devices

FDA 510(k) Submission Details - K980788

510(k) Number K980788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1998
Decision Date May 22, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
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.

JDW Device Classification - Class 2, Special Controls

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 64
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K980788.
TAC' PIN
K993910 · New Deal, S.A. · Feb 2000
DEPUY ROCKWOOD CLAVICLE PIN
K991649 · Depuy, Inc. · Jul 1999
HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM
K982068 · Howmedica Corp. · Aug 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186 · Orthofix Srl · Mar 1998
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · Synthes (Usa) · Mar 1997
HANSSON PIN SYSTEM
K964893 · Osteonics Corp. · Feb 1997