FRAGMENT SPECIFIC FIXATOR

K052498 · David J. Slutsky MD · KTT · Oct 17, 2005 · Orthopedic

Device Facts

• Record ID: K052498
• Device Name: FRAGMENT SPECIFIC FIXATOR
• Applicant: David J. Slutsky MD
• Product Code: KTT · Orthopedic
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fragment Specific fixator is intended for use in the geriatric population who have sustained an unstable extra-articular distal radius fracture that cannot be managed by casting, or a 3- or 4-part intra-articular fracture provided the medial fragment is large enough for the insertion of 2 separate 2.5mm - 3.0mm threaded cortical pins. The device can be used in a nonjoint bridging configuration which allows for immediate wrist motion during the fracture healing period of 6-8 weeks. It may alternatively be used in a joint bridging manner to provide ligamentotaxis to obtain and maintain the fracture reduction during the healing period.

Device Story

External fixator for distal radius fractures; provides stable fixation via self-drilling bone pins. Lightweight, radiolucent construct; used in non-joint bridging configuration (allowing wrist motion) or joint-bridging configuration (using ligamentotaxis for reduction). Operated by surgeons in clinical settings. Device captures bone fragments to maintain reduction during 6-8 week healing period. Benefits include stable fixation and potential for early mobilization.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

External fixator; lightweight, radiolucent materials; utilizes self-drilling bone pins (2.5mm-3.0mm threaded cortical pins).

Indications for Use

Indicated for geriatric patients with unstable extra-articular distal radius fractures unmanageable by casting, or 3- to 4-part intra-articular fractures with medial fragments sufficient for two 2.5mm-3.0mm threaded cortical pins.

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

• Wristore Distal Radius Fracture Fixator (K042761)
• Hoffmann II Micro External Fixation System (K050048)

Submission Summary (Full Text)

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K052498

# JCT 17 2005

# 510(k) Summary

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| Submitter: | David J. Slutsky M.D.<br>South Bay Hand Surgery Center<br>3475 Torrance Blvd., Ste F<br>Torrance, CA 90503 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | David J. Slutsky M.D.<br>Phone: [phone]<br>FAX: [phone] |
| Date: | September 10, 2005 |
| Trade Name: | Fragment Specific Fixator |
| Common Name: | External Fixator |
| Classification Name: | Smooth or threaded metallic bone fixation fastener.<br>Single/multiple component metallic bone fixation<br>appliances and accessories. |
| Classification Reference: | 21 CFR 888.3040, 3030 |
| Predicate Devices: | Millennium Medical Technologies, Inc., Wristore<br>Distal Radius Fracture Fixator, K042761, cleared<br>November 17, 2004.<br>Howmedica Osteonics Corp., Hoffmann II Micro<br>External Fixation System, K050048, cleared March<br>4, 2005. |
| Device Description: | The Fragment Specific Fixator is a single use<br>external fixator designed to provide stable fracture<br>fixation in a nonjoint bridging application that does<br>not cross the wrist or in a joint bridging application<br>that obtains and maintains fracture reduction<br>through ligamentotaxis. The lightweight, radiolucent<br>construct attaches to self drilling bone pins to<br>provide secure fracture fixation and to capture<br>fragments. |
| Intended Use: | The Fragment Specific fixator is intended for use in |
| | the geriatric population who have sustained an<br>unstable extra-articular distal radius fracture that<br>cannot be managed by casting, or a 3- or 4-part<br>intra-articular fracture provided the medial fragment<br>is large enough for the insertion of 2 separate<br>2.5mm - 3.0mm threaded cortical pins. The device<br>can be used in a nonjoint bridging configuration<br>which allows for immediate wrist motion during the<br>fracture healing period of 6-8 weeks. It may<br>alternatively be used in a joint bridging manner to<br>provide ligamentotaxis to obtain and maintain the<br>fracture reduction during the healing period. |
| Comparison to Predicate Device: | The Fragment Specific Fixator has the same<br>intended use, has similar performance<br>characteristics, is manufactured from similar<br>materials using similar processes, and is similar in<br>design to the predicate devices. |
| Performance Data: | The results of non-clinical (laboratory) performance<br>testing demonstrate that the device is safe and<br>effective. |

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OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

David J. Slutsky, M.D. South Bay Hand Surgery Center 3475 Torrance Boulevard, Suite F Torrance, California 90503

Re: K052498 Trade/Device Name: Fragment Specific Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bonc fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 10, 2005 Received: September 12, 2005

Dear Dr. Slutsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becomed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 conniner co may 20, 1978) in accordance with the provisions of the Federal Food, Drug, de vices that have occh receasined in quire approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controls proving 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 may be subject to back adderal 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 r rouse or hose made a determination that your device complies with other requirements of the Act that 1197 has intatutes and regulations administered by other Federal agencies. You must or any I 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 - David J. Slutsky, M.D.

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 premated nevice 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 in you don't office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other Echeral International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincercly yours,

2

Cow Mark N. Melkerson Acting 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

### 510(k) Number: 052498

### Device Name: Fragment Specific Fixator

Indications for Use:

The Fragment Specific fixator is intended for use in adult male and females from The Tragment Openiation who have sustained an unstable extra-SKeletal maturity to the gonation in managed by casting, or a 3- or 4-part intraarticular fracture provided the medial fragment is large enough for the insertion of 2 anticular nacture provided the modial nagli pins. The device can be used in a nonjoint Separate 2.0mm - 0.0mm thrallows for immediate wrist motion during the fracture bridging configuration which allowy alternatively be used in a joint bridging manner to nealing perfou of o o woner in and maintain the fracture reduction during the healing period.

Prescription Use XXXX (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter Use -(21 CFR 801 Subpart C)

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

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________