Cleared Traditional

K150661 - ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite

K150661 is an FDA 510(k) clearance for ST.A.R. 90 F4 External Fixation Screws ..., manufactured by Citieffe S.R.L.. The device is a Class 2 Orthopedic device with product code JDW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K150661 · Citieffe S.R.L. · Orthopedic device
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Jul 2015
Decision
116d
Days
Class 2
Risk

K150661 is an FDA 510(k) clearance for the ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Citieffe S.R.L. (Calderara Di Reno, IT). The FDA issued a Cleared decision on July 7, 2015 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Citieffe S.R.L. devices

FDA 510(k) Submission Details - K150661

510(k) Number K150661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2015
Decision Date July 07, 2015
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
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 Consultant

THEMA S.r.l.
Marisa Testa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDW Pin, Fixation, Threaded

All 85
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K150661.
Temporary Fixation Pins
K192768 · Eisertech, LLC · Dec 2019
SMV Scientific K-Wire and Pins
K182171 · Summit Medventures · Oct 2018
Ultima HA Coated Half Pins and Wire
K163487 · Vilex IN Tennessee, Inc. · Feb 2017
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820 · Vilex, Inc. · Jul 2014
OPTOSSOL COMPRESSION DEVICE SYSTEM
K140875 · Genossis, LLC · May 2014
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459 · Aap Implantate AG · Oct 2013