OSTEO-CABLE SLEEVE

K024022 · Biomet, Inc. · HXN · Jan 23, 2003 · Orthopedic

Device Facts

• Record ID: K024022
• Device Name: OSTEO-CABLE SLEEVE
• Applicant: Biomet, Inc.
• Product Code: HXN · Orthopedic
• Decision Date: Jan 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.4540
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as: - Femur And Tibial Fractures . - Prophylactic Banding . - Trochanteric Reattachment . - Olecranon Fractures ● - Patella Fractures ● - Ankle Fractures ● - Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques . - Sternum Fixation After Open Heart Surgery ● - Stabilization Of Cortical Onlay Strut Graft .

Device Story

Osteo-cable Sleeve is a bone fixation component used in orthopedic surgery. It functions as a wedge-shaped sleeve with two longitudinal holes for cable passage, designed to secure bone fragments or grafts. The device is implanted by surgeons during orthopedic procedures to provide mechanical stabilization. It features a thin plate with small spikes on the bottom to prevent migration. By securing cables against bone, it facilitates fracture healing and graft stability. The device is a single-piece construction, eliminating the need for assembly during the procedure.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing.

Technological Characteristics

Material: 316 LVM stainless steel. Form factor: Wedge-shaped sleeve with two longitudinal cable holes and a thin plate with anti-migration spikes. Single-piece machined construction. Non-powered, mechanical fixation device.

Indications for Use

Indicated for patients requiring general orthopedic repairs including femur/tibial fractures, prophylactic banding, trochanteric reattachment, olecranon/patella/ankle fractures, spiral fracture fixation with I/M nailing/screwing, sternum fixation post-open heart surgery, and cortical onlay strut graft stabilization.

Regulatory Classification

Identification

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Predicate Devices

• Biomet's BMP™ Cable System (K982545)

Submission Summary (Full Text)

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

K024022
page 1 of 1

## SUMMARY OF SAFETY AND EFFECTIVENESS

JAN 2 3 2003

| Applicant or Sponsor: | Biomet Orthopedics, Inc<br>56 E. Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0587 |
|------------------------|--------------------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA<br>Telephone: [phone]<br>Fax: [phone] |
| Proprietary Name: | Osteo-cable Sleeve |
| Common or Usual Name: | Bone Screw |
| Device Classification: | Screw, Fixation, Bone (888.3040) |
| Device Product Code: | 87HWC |

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Biomet's BMP™ Cable System (K982545)

Indications for Use: The Cable Sleeve is indicated for general orthopedic repairs, such as:

- Femur and Tibial Fractures ●
- Prophylactic banding .
- Trochanteric reattachment .
- Olecranon fractures .
- Patella fractures ●
- Ankle fractures .
- Fixation of spiral fractures in conjunction with I/M nailing and screwing techniques .
- Sternum fixation after open heart surgery ●
- Stabilization of cortical onlay strut graft .

Device Description: The device modified is the cable sleeve used in the Biomet's BMP™ Cable System (K982545), P/Ns 350805 and 350813/21. No other parts of this system are being modified. The device is machined from a single piece of 316 LVM stainless steel, eliminating assembly of any components. The device profile is in the shape of a wedge with two longitudinal holes that run the length of the part. The holes allow for cables to be passed through during surgery. The narrow end of the wedge has a thin plate to increase surface area. There are small spikes on the bottom of the plate to help eliminate migration of the plate.

Non-Clinical Testing: Mechanical testing demonstrated the modified device performed as well as or better than the previously marketed devices

Clinical Testing: Clinical testing was not used to establish substantial equivalence.

| MAILING ADDRESS<br>P.O. Box 587<br>Warsaw, IN 46581-0587 | | SHIPPING ADDRESS<br>56 E. Bell Drive<br>Warsaw, IN 46582 | | | |
|----------------------------------------------------------|--|----------------------------------------------------------|--|--|------------------------------|
| OFFICE<br>574.267.6639 | | FAX<br>574.267.8137 | | | E-MAIL<br>[e-mail] |

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Public Health Service

JAN 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kacy Arnold, RN, MBA Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K024022

Trade Name: Osteo-Cable Sleeve Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: II Product Code: HXN and JDQ Dated: January 14, 2003 Received: January 15, 2003

Dear Ms. Arnold:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.

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

Page 2 - Ms. Kacey Arnold. RN. MBA

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 [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 Manufacturers, International 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 Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

BIOMET

Page _1_ of _1_

510 (k) Number (if known): k024922

## Device Name: Osteo-cable Sleeve

Indications for Use: The Osteo-cable Sleeve is indicated for general orthopedic repairs, such as:

- Femur And Tibial Fractures .
- Prophylactic Banding .
- Trochanteric Reattachment .
- Olecranon Fractures ●
- Patella Fractures ●
- Ankle Fractures ●
- Fixation Of Spiral Fractures In Conjunction With I/M Nailing And Screwing Techniques .
- Sternum Fixation After Open Heart Surgery ●
- Stabilization Of Cortical Onlay Strut Graft .

to Mark N. Milkersen

Division Si ivision of General, Restorative and Neurological Devices

Number 1/23/03

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
|---------------------------------------|----|-----------------------------------------------|
|---------------------------------------|----|-----------------------------------------------|

| MAILING ADDRESS | P.O. Box 587<br>Warsaw, IN 46581-0587 |
|------------------|---------------------------------------|
| SHIPPING ADDRESS | 56 E. Bell Drive<br>Warsaw, IN 46582 |

| OFFICE | 574.267.6639 |
|--------|-------------------|
| FAX | 574.267.8137 |
| E-MAIL | [e-mail] |

8