K Number
K071394
Device Name
MODIFICATION TO:SBI RINGFIX
Date Cleared
2007-06-29

(39 days)

Product Code
Regulation Number
888.3030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RingFIXTM System is intended for: 1. fracture fixation (open and closed) 2. pseudarthrosis or nonunions of long bones 3. limb lengthening by epiphyseal or metaphyseal distraction 4. correction of bony or soft tissue deformities 5. correction of segmental bony or soft tissue defects
Device Description
This Special 510(k) Submission is intended to add additional components to the RingFIX™ System
More Information

Not Found

No
The summary describes a mechanical ring fixator system and does not mention any AI or ML components or functionalities.

Yes
The device is described as a system for "fracture fixation (open and closed)", "pseudarthrosis or nonunions of long bones", "limb lengthening by epiphyseal or metaphyseal distraction", and "correction of bony or soft tissue deformities" and "correction of segmental bony or soft tissue defects", all of which are therapeutic interventions.

No
The device is described as a system for fracture fixation, pseudarthrosis/nonunions, limb lengthening, and correction of deformities/defects, indicating a therapeutic or corrective function rather than a diagnostic one.

No

The device description explicitly states it is adding "additional components" to a "RingFIX™ System," which is a physical fracture fixation system (as indicated by the predicate device). This implies the device includes hardware components, not just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly describes a device used for surgical procedures on bones (fracture fixation, limb lengthening, deformity correction, etc.). This is a therapeutic and structural function, not a diagnostic one performed on in vitro samples.
  • Device Description: The description mentions adding components to a "RingFIX™ System," which is consistent with a surgical fixation device.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in a laboratory setting, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The RingFIX™ System's function is to physically support and manipulate bone structures within the body.

N/A

Intended Use / Indications for Use

The RingFIXTM System is intended for:

    1. fracture fixation (open and closed)
    1. pseudarthrosis or nonunions of long bones
    1. limb lengthening by epiphyseal or metaphyseal distraction
    1. correction of bony or soft tissue deformities
    1. correction of segmental bony or soft tissue defects

Product codes

KTT

Device Description

This Special 510(k) Submission is intended to add additional components to the RingFIX™ System

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

long bones

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The Design Control Activities Summary demonstrates that the the modified device met all of the pre-determined acceptance criteria. The modified RingFIX™ System will achieve the same stability as afforded by the currently available RingFIX™ System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K890814

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.

0

JUN 2 9 2007

510(k) Summary

| Manufacturer: | Small Bone Innovations
1711 South Pennsylvania Avenue
Morrisville, PA 19067
215-428-1791
215-428-1795 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations
1711 South Pennsylvania Avenue
Morrisville, PA 19067 |
| Proprietary Name: | SBi RingFIX™ System |
| Classification name: | Class II, 888.3030 - Single/multiple component metallic
bone fixation appliances and accessories |
| Product Code: | KTT - Appliance, Fixation, Nail/Blade/Plate Combination,
Multiple Component |
| Common/Usual Name: | Single/multiple component metallic bone fixation
appliances and accessories |
| Substantial Equivalence: | The modified SBi RingFIX™ System shares the same
intended use and fundamental scientific technology as that
of the currently available RingFIX™ System (originally
cleared as the Danek Ring Fixator in K890814). The
Design Control Activities Summary demonstrates that the
the modified device met all of the pre-determined
acceptance criteria. The modified RingFIX™ System will
achieve the same stability as afforded by the currently
available RingFIX™ System. |
| Description: | This Special 510(k) Submission is intended to add
additional components to the RingFIX™ System |

.

1

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Small Bone Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Robert Hoehn Senior Regulatory Associate 505 Park Avenue, 14th Floor New York, New York 10022

JUN 2 9 2007

Re: K071394

Trade/Device Name: SBi RingFIX™ System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: June 11, 2007 Received: June 14, 2007

Dear Mr. Hoehn:

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

2

Page 2 - Mr. Robert Hoehn

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. 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 Office of Compliance at (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely your

fur Raths

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

Enclosure

3

Indications for Use

K071394 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: RingFIXTM System

Indications For Use:

The RingFIXTM System is intended for:

    1. fracture fixation (open and closed)
    1. pseudarthrosis or nonunions of long bones
    1. Iimb lengthening by epiphyseal or metaphyseal distraction
    1. correction of bony or soft tissue deformities
    1. correction of segmental bony or soft tissue defects

Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (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 Sign-On)
Division of General, Restorative,
Division of General, Devices Division of Overological Devices 510(k) Number_