ORTHOSORB LS

K140625 · Biomet, Inc. · OVZ · Apr 18, 2014 · Orthopedic

Device Facts

• Record ID: K140625
• Device Name: ORTHOSORB LS
• Applicant: Biomet, Inc.
• Product Code: OVZ · Orthopedic
• Decision Date: Apr 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; 2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities. 3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.

Device Story

OrthoSorb LS is a resorbable fixation device consisting of straight and tapered pins. Fabricated from a copolymer of L-lactic and glycolic acids, the device provides mechanical stabilization for bone fragments. It degrades in-vivo via hydrolysis into L-lactic and glycolic acids, which are metabolized by the body. Used by surgeons in clinical settings for orthopedic procedures in the hand and foot, including fracture fixation, osteotomies, and joint arthroplasty. The device is implanted to maintain fragment position during the healing process, eliminating the need for secondary removal surgery due to its resorbable nature.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, specifically four-point bending (ASTM D6272) and single shear testing.

Technological Characteristics

Resorbable copolymer of L-lactic and glycolic acids. Straight and tapered pin form factors. Mechanical properties validated via ASTM D6272 (four-point bending) and single shear testing. Resorption occurs via in-vivo hydrolysis.

Indications for Use

Indicated for fixation of small bony/chondral fragments in knee/hand (non-tension), stable osteotomies of great toe/first metatarsal, intramedullary stabilization of joint arthroplasty for lesser toe deformities, and supplemental support for finger joint fusion/digit replantation.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Depuy's Orthosorb Resorbable Pins (K901456 and K111077)
• Biomet's LactoSorb Bone Pin (K990291)

Submission Summary (Full Text)

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APR 1 8 2014

### 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| Submitted by: | Biomet Trauma<br>56 East Bell Drive<br>PO Box 587<br>Warsaw, IN 46581<br>Phone: [phone]<br>Fax: [phone] |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Victoria Scheitlin, Regulatory Affairs Specialist |
| Date Prepared: | March 2014 |
| Proprietary Name: | OrthoSorb LS |
| Common Name: | Pin, Fixation, Reabsorbable, Hard Tissue |
| Classification Name<br>/ Product Code: | Smooth or threaded metallic bone fixation fastener. (21 CFR<br>§ 888.3040) / OVZ |
| Predicate Devices: | Biomet's OrthoSorb LS is substantially equivalent to the<br>currently marketed devices: Depuy's Orthosorb Resorbable<br>Pins (K901456 and K111077), and Biomet's LactoSorb Bone<br>Pin (K990291). |
| Device Description: | Biomet OrthoSorb LS resorbable fixation devices include<br>straight and tapered pins. Biomet OrthoSorb LS resorbable<br>fixation devices are made of a resorbable copolymer,<br>polyester derivative of L-lactic and glycolic acids. Poly L-<br>lactic/polyglycolic acid copolymer degrades and resorbs in-<br>vivo by hydrolysis into L-lactic and glycolic acids which are<br>then metabolized by the body. |
| Indications for Use: | 1.) To fix in place small bony or chondral fragments in the<br>knee and hand where such fragments are not in tension, as<br>in the case of osteochondritis dissecans or fractures of the<br>phalanges and metacarpals; |

、

2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of

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' joint arthroplasty (resection) for the treatment of lesser toe deformities.

3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed. \

Technological Characteristics: The technological characteristics of OrthoSorb LS are similar to currently marketed devices including design, dimensions, and material.

Summary of Substantial Equivalence: OrthoSorb LS is substantially equivalent to currently marketed devices demonstrated through mechanical testing that was performed to ASTM D6272, which highlights the method for flexural properties, specifically testing protocol four-point bending. Single Shear testing was also performed which represents a common loading condition observed invivo during which the bone pin is used to fix bony fragments No new issues of safety or efficacy have been raised.

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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 the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem consisting of three abstract shapes that resemble human figures or flowing forms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### April 18, 2014

Biomet Trauma Ms. Victoria Scheitlin Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581

Re: K140625

Trade/Device Name: OrthoSorb LS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OVZ Dated: March 7, 2014 Received: March 11, 2014

Dear Ms. Scheitlin:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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#### Page 2 - Ms. Victoria Scheitlin

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

:"

Sincerely yours,

# Mark N. Melkerson -S

- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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#### Indications for Use Statement

510(k) Number:

## K140625

Device Name:

OrthoSorb LS

#### Indications For Use:

1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals;

2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities.

3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR Over-the-Counter (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)

.

# Elizabeth L. Erank -S

Division of Orthopedic Devices