Cleared Special

K993004 - ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW

K993004 is an FDA 510(k) clearance for ALTA FULLY THREADED CROSS-LOCKING 5.0 M..., manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Special 510(k) pathway after a 29-day FDA review.

K993004 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
29d
Days
Class 2
Risk

K993004 is an FDA 510(k) clearance for the ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Rutherford, US). The FDA issued a Cleared decision on October 6, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K993004

510(k) Number K993004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1999
Decision Date October 06, 1999
Days to Decision 29 days
Submission Type Special
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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

JDS Device Classification - Class 2, Special Controls

Product Code JDS Nail, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDS Nail, Fixation, Bone

All 41
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K993004.
BNF
K021782 · Aap Implantate AG · Aug 2002
SYNTHES PROXIMAL HUMERAL NAIL
K002729 · Synthes (Usa) · Oct 2000
PEDIATRIC FIXATION RODS
K000764 · Biomet, Inc. · Apr 2000
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
K992348 · Synthes (Usa) · Sep 1999
MACMED PAEDIATRIC INTRAMEDULLARY NAIL
K991877 · Innervision, Inc. · Aug 1999
EUCLID REDUCTION AND GUIDANCE SYSTEM
K991037 · Modular Cutting Systems, Inc. · Jun 1999