PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)

K081608 · Toby Orthopaedics, LLC · HRS · Dec 19, 2008 · Orthopedic

Device Facts

• Record ID: K081608
• Device Name: PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
• Applicant: Toby Orthopaedics, LLC
• Product Code: HRS · Orthopedic
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Device Story

Proximal Humerus Scaffold Fixation System (PHSFS) is a metallic bone fixation system for proximal humeral fractures; consists of titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture, and custom sterilization container. Used by surgeons in clinical settings to stabilize bone segments during fracture repair, osteotomy, or non-union treatment. Provides mechanical fixation to facilitate bone healing.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical performance comparisons and compliance with FDA-recognized consensus standards (ASTM F136-02a, ASTM F899-07).

Technological Characteristics

Materials: Wrought Titanium-6 Aluminum-4 Vanadium ELI alloy (ASTM F136-02a) for implants; Stainless Steel (ASTM F899-07) for instruments. System includes plate, posts, cross-pegs, cortical screws, K-wires, and alignment fixture. Mechanical fixation device; non-powered; non-software.

Indications for Use

Indicated for patients with fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

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 LCP Proximal Humerus Plate

Submission Summary (Full Text)

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Image /page/0/Figure/2 description: This document is a summary of safety and effectiveness for the Proximal Humerus Scaffold Fixation System (PHSFS). It was submitted by TOBY Orthopaedics, located at 3773 Matheson Avenue in Miami, Florida 33133, with the phone number 1 [phone]. The document is dated December 19, 2008, and the contact person is Al Weisenborn. The device trade name is Proximal Humerus Scaffold Fixation System (PHSFS), the common name is Shoulder Plate, and the classification name is Single/multiple component metallic bone fixation appliances and accessories per 21 CFR § 888.3030.

## Identification of a Legally Marketed Predicate Device

The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) is substantially equivalent to Synthes LCP Proximal Humerus Plate that is legally marketed and distributed by Synthes (USA).

### Device Description

The Proximal Humerus Scaffold Fixation System (PHSFS) is intended for the repair of proximal humeral fractures. The system consists of a titanium plate, posts, cross-pegs, cortical screws, 1.5 mm K-Wires, manual surgical instruments, alignment fixture and a custom sterilization container.

### Intended Use

The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

### Summary of Technological Characteristics

A 15-point comparison of technological characteristics and a 4-point comparison of performance characteristics of the TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) and the predicate device were performed. The devices were found to be substantially equivalent.

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## Summary of Performance Data

The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) complies with the requirements of listed FDA Recognized Consensus Standards.

- ASTM F136-02a, Standard Specification for Wrought Titanium-6 Alumi-num-4 . Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401))
- ASTM F899-07, Standard Specification for Stainless Steel for Surgical In-. struments

The TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS) is substantially equivalent to Synthes LCP Proximal Humerus Plate that is legally marketed and distributed by Synthes (USA) This has been demonstrated through a 15-point technological comparison of features and a multi-parameter comparison of mechanical performance.

The implantable and tissue contact materials used to fabricate the Proximal Humerus Scaffold Fixation System (PHSFS) and Instruments have a long history of safe usage in medical devices. Because the TOBY Orthopaedics Proximal Humerus Scaffold Fixation System (PHSFS)s meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

DEC 1 9 2008

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TOBY Orthopaedics, LLC % Mr. Al Weisenborn 3773 Matheson Avenue Miami, Florida 33133

Re: K081608

Trade/Device Name: Proximal Humerus Scaffold Fixation System (PHSFS) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: September 25, 2008 Received: November 28, 2008

Dear Mr. Weisenborn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Mr. Al Weisenborn

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. Millenson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| | Indications for Use | |
|---------------------------|---------------------------------------------------|--|
| Page 1 of 1 | | |
| 510(k) Number (if known): | K081608 | |
| Device Name: | Proximal Humerus Scaffold Fixation System (PHSFS) | |
| Indications for Use: | | |

The Proximal Humerus Scaffold Fixation System (PHSFS) is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

| Prescription Use X<br>(Per 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|--------------------------------------------------|--------|------------------------------------------------|
|--------------------------------------------------|--------|------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K081608 |
|---------------|---------|
|---------------|---------|

TOBY Orthopaedics

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