Piccolo Composite Nail System – CARBOFIX Orthopedics

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number07290117350676 UDI-DI	Date5 Dec 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Special	NumberK153536	Date6 Jan 2016Cleared	StatusActive
United States	FDA 510(k) 510(k)	NumberK151010	Date28 Jul 2015Issued	StatusActive

Official records

AccessGUDID record UDI-DI 07290117350676
FDA 510(k) database 510(k) number K153536
FDA 510(k) database 510(k) number K151010

Across registries

2 registries list this device

FDA 510(k) K153536 decided 6 Jan 2016 Active· +1 more in the status table
FDA GUDID UDI-DI 07290117350676 listed 5 Dec 2022 Listed

Recalls

1 recall · FDA

- Terminated Z-1991-2016 FDA Class II initiated 10 May 2016
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

Timeline

4 dated events

28 Jul 2015 Cleared FDA 510(k) K151010
6 Jan 2016 Cleared FDA 510(k) K153536
10 May 2016 Recall initiated FDA recalls Z-1991-2016
5 Dec 2022 Listed FDA GUDID 07290117350676

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name: Orthopaedic implant aiming arm
Model / Ref / Catalog: Stopper Screw, PPF910980
FDA applicant: CarboFix Orthopedics , Ltd.

Primary DI / UDI-DI: 07290117350676
510(k) Number: K153536
K151010
FDA product code: HSB
GMDN term: Orthopaedic implant aiming arm

Device class: Class II
Regulation: 21 CFR Part 888.3020
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Piccolo Composite Nailing System K132774 3 Oct 2013 via K151010 FDA record · FDA summary
Piccolo Composite Ankle Arthrodesis Nailing System K123810 14 Jun 2013 via K151010 FDA record · FDA summary
Piccolo Composite Nailing System K111056 3 May 2011 via K153536 FDA record · FDA summary
Piccolo Composite Nailing System K102369 31 Jan 2011 via K153536 FDA record · FDA summary
Quantum Im Composite Nailing System (Quantum Nailing System) K100497 21 Jun 2010 via K151010 FDA record · FDA summary
Quantum M Composite Nailing System K091425 21 Jan 2010 via K151010 FDA record · FDA summary
GAMMA3 Nail System K043431 16 Feb 2005 via K151010 FDA record
Modification To Fixion Interlocking Proximal Femoral Intramedullary Nailing System K012967 4 Oct 2001 via K151010 FDA record
Synthes (Usa) Trochanteric Fixation Nail (Tfn) System K011857 12 Sep 2001 via K151010 FDA record
Fixion Interlocking Proximal Femoral Nailing System K010988 19 Jun 2001 via K151010 FDA record

Cited by

Piccolo Composite Nailing System K173652 28 Dec 2017 via K151010 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Piccolo Composite Nailing System is a Proximal Femoral Nail (Device Type: HSB) designed for internal fixation of proximal femur fractures. It consists of a composite cylindrical nail with a tapered design—11 mm mid-shaft diameter expanding to 17 mm proximally—alongside locking screws to stabilize pertrochanteric, intertrochanteric, and high subtrochanteric fractures, including complex fracture patterns.

This system is supplied as a reusable surgical implant set, including nails in lengths of 180 mm, 200 mm, and 300–460 mm, alongside dedicated instrumentation. It is intended for use in orthopedic trauma settings and has received FDA 510(k) clearance under the Traditional pathway, classified under the Orthopedic Advisory Committee. Sterility and MRI safety are not specified in the submitted data.

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Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)