Who is the manufacturer of TITANIUM UNIVERSAL CLAMP?

Synthes (Usa) filed the 510(k) submission for TITANIUM UNIVERSAL CLAMP (K960269).

What is the FDA product code for TITANIUM UNIVERSAL CLAMP?

LXT. It is classified under 21 CFR 888.3030 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for TITANIUM UNIVERSAL CLAMP?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TITANIUM UNIVERSAL CLAMP?

Synthes Double Adjustable Clamp (K960269).

Who can help prepare an FDA 510(k) submission like TITANIUM UNIVERSAL CLAMP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TITANIUM UNIVERSAL CLAMP

K960269 · Synthes (Usa) · LXT · Apr 4, 1996 · Orthopedic

Device Facts

Record ID	K960269
Device Name	TITANIUM UNIVERSAL CLAMP
Applicant	Synthes (Usa)
Product Code	LXT · Orthopedic
Decision Date	Apr 4, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3030
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Synthes Ti Universal Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation.

Device Story

External fixation frame component; connects Schanz screws (pins) to 11 mm carbon fiber rods or stainless steel tubes; available in 4-pin and 6-pin configurations for variable pin spreads; used by surgeons in clinical settings to stabilize long bone fractures; provides structural support for bone healing.

Clinical Evidence

Bench testing only; mechanical test results demonstrate substantial equivalence to predicate.

Technological Characteristics

Material: Titanium Alloy. Form factor: Clamp with 4 or 6 pin positions. Connectivity: None. Sterilization: Not specified. Energy source: None (mechanical).

Indications for Use

Indicated for patients with long bone fractures requiring external fixation.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Synthes Double Adjustable Clamp (K960269)

Related Devices

K960014 — PRACTIFIX EXTERNAL FIXATION SYSTEM · Orthopaedic Innovations, Inc. · Mar 18, 1996
K230067 — Para-Fix External Fixation System · New Paradigm Biomedical · Sep 22, 2023
K101338 — NEWFIX EXTERNAL FIXATION SYSTEM · Technologia Y Diseno Industrial, S.A DE C.V · Mar 14, 2011
K961916 — HOFFMANN II CARBON CONNECTING ROD · Howmedica, Inc. · Aug 1, 1996
K140675 — EMERGE EXTERNAL FIXATION SYSTEM · Emerge Medical, Inc. · Jun 10, 2014

Submission Summary (Full Text)

{0} SYNTHES K 960269 K960269 Attachment VII: Summary of Safety and Effectiveness Information [510(k) Summary] | Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301 | (610) 647-9700 Contact: Angela J. Silvestri January 16, 1996 | APR - 4 | | --- | --- | --- | Synthes Ti Universal Clamp is compared to Synthes Double Adjustable Clamp. Synthes Ti Universal Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the Schanz screws (pins) to an 11 mm carbon fiber rod or stainless steel tube. The Ti Universal Clamp is available in 2 sizes: four and six possible pin positions, which allow variable pin spreads in a two pin model. The device is manufactured from a Titanium Alloy. Synthes Double Adjustable Clamp is intended for use in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The clamps attach the Schanz screws (pins) to a carbon fiber rod or stainless steel tube. The Double Adjustable Clamp has three possible pin positions, to allow variable pin spreads in a two pin model. The device is manufactured from stainless steel. Based on mechanical test results, the Ti Universal Clamp has been found to be substantially equivalent to the Double Adjustable Clamp.