R&R EXTERNAL FIXATION SYSTEM

K052005 · R&R Medical, Inc. · KTT · Sep 6, 2005 · Orthopedic

Device Facts

• Record ID: K052005
• Device Name: R&R EXTERNAL FIXATION SYSTEM
• Applicant: R&R Medical, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Sep 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna. The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

Device Story

R&R External Fixation System comprises Ring Fixator and Unilateral Mini Fixator assemblies; used for bone fracture stabilization, lengthening, and deformity correction. Ring Fixator utilizes bone anchorage elements (pins/wires), bridge elements (rings/arches), and connection elements (struts/clamps) to provide stable fixation, axial loading, and joint range of motion. Unilateral Mini Fixator allows multi-planar pin placement, precise compression/distraction, and linear translation for small bone fractures or arthrodesis. Devices are applied by surgeons in clinical settings to stabilize bone fragments, facilitate healing, and enable early weight-bearing. Output is mechanical stabilization of the skeletal structure.

Clinical Evidence

bench testing only

Technological Characteristics

Metallic bone fixation system consisting of pins, wires, rings, arches, struts, and clamps. Provides multi-planar fixation and adjustable compression/distraction. Mechanical assembly; no energy source or software components.

Indications for Use

Indicated for patients requiring stabilization of open/closed fractures, pseudoarthrosis, nonunions, limb lengthening, or deformity correction in long bones (tibia, fibula, femur, humerus, radius, ulna) and small bones (metacarpal, metatarsal, ulnar, calcaneal).

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

• True/Lok Monolateral/Bilaterial (K941048)
• DFS® MiniFixator (K951357/K970290)
• Small Bone External Fixation System (Acumed)

Submission Summary (Full Text)

{0}------------------------------------------------

## 510(k) Summary R&R External Fixator System

K05 2005

| Date | July 20, 2005 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | R&R Medical, Inc.<br>2225 Park Place Drive<br>Slatington, Pa. 18080 |
| Contact person | J.D. Webb<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>512-388-0199 |
| Trade Name | R&R External Fixation System |
| Common name | External fixation frame |
| Classification name | Single/multiple component metallic bone fixation appliances and accessories<br>Class II per 21 CFR section 888.3030 |
| Product Code | KTT |
| Equivalent Device | True/Lok Monolateral/Bilaterial (Applied Osteo Systems, K941048)<br>DFS® MiniFixator (EBI, K951357/K970290)<br>Small Bone External Fixation System (Acumed) |

## Device Description

The R&R Ring Fixator assembly consists of three basic types of elements: 1) bone anchorage elements, 2) bridge elements, and 3) connection elements. The Ring Fixator design allows freedom of pin placement, ease of assembly and stable fixation of bone fragments with the possibility of axial loading of the extremity and immediate range of motion of all adjacent joints.

Bone anchorage elements include pins and wires. Bridge elements include rings or arches and extensions. Connection elements include struts, nuts and bolts, wire fixation bolts and pin clamps.

The R&R Unilateral Mini Fixator is a stable solution for fractures and for lengthening of small bones. The system allows precise, controlled compression / distraction and early weight bearing, The articulating pin clamps allow adjustment around three axes and linear translation so that it can be used for comminuted intra-articular fractures, joint stiffness, or arthrodesis of the foot or hand. The fixator design enables pins to be located in multi-planar arrangements, allowing the frame to be built around the fractures in the hand or foot.

## Intended Use

The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Public Health Service

SEP - 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

R & R Medical, Inc. c/o J.D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K052005 R092009
Trade/Device Name: R & R External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 20, 2005 Received: July 25, 2005

Dear J.D. Webb:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Security (10(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substantially interstate referenced above and nave determined the arrood at devices marketed in interstate for use stated in the encrosure) to regary manceded provice Amendments, or to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance was as a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previous of the Act . The and Cosment Act (Act) that do not require approvine as a controls provisions of the Act. The Act. The You may, merelove, market the devices, subject to the go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Fist listed on and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classifica (see above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major regal consected t may be subject to such additional controls. Extrong might of the 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Ood of I satist one one --------------------------------------------------------------------------------------------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buccession a suith other requirements of the Act
that FDA has made a determination that your device complies with other may that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations administers. of economics, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sets CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1950 form in the quality systems (QD) regalaren (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - J.D. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter wifi anow you to ogin maing of substantial equivalence of your device to a legally prematicated predicated. The PDF interness to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acroliance at [phone]. Also, please note the regulation entitled, Connact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small biller general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

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

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: R&R External Fixation System

Indications for Use:

The R&R Ring Fixator and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction or bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects. The R&R Ring Fixator is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.

The R&R Unilateral Fixator is indicated for stabilizing various fractures including open and/or comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metacarpal, metatarsal, ulnar, and calcaneal bones.

Prescription Use _ X_ Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_Kos2005