AESCULAP RESORBABLE PIN, MODEL FR735

K070178 · Aesculap Implant System, Inc. · MAI · Apr 30, 2007 · Orthopedic

Device Facts

• Record ID: K070178
• Device Name: AESCULAP RESORBABLE PIN, MODEL FR735
• Applicant: Aesculap Implant System, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Apr 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.

Device Story

Aesculap Resorbable Pin is a small orthopedic fixation device; manufactured from Poly-L,DL-Lactide (70/30) copolymer; designed to be absorbed by the body over time. Used by surgeons in clinical settings for fixation of non-load bearing bone fragments, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair. Device provides mechanical stabilization of tissue/bone fragments during healing process; material degrades post-implantation, eliminating need for secondary removal surgery. No electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Poly-L,DL-Lactide (70/30) copolymer. Form factor: Small orthopedic fixation pin. Principle: Biodegradable mechanical fixation. No energy source, connectivity, or software.

Indications for Use

Indicated for fixation of non-load bearing bone fragments, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.

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

• Arthrex Meniscal Dart System (K983577)
• Bionx Smart Nail from ConMed Linvatec (K993074)

Submission Summary (Full Text)

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K070178

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## C. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

[in Accordance with SMDA of 1990]

#### Aesculap Resorbable Pin

25 April 2007

APR 3 € 2007

COMPANY: Aesculap® Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311

CONTACT: Matthew M. Hull, Regulatory Affairs Manager 800 258-1946 x 5072 (phone) 610 791-6882 (fax)

- Aesculap® Resorbable Pin TRADE NAME:
- COMMON NAME: Resorbable Orthopedic Pin

DEVICE CLASS: Class II

PRODUCT CODE: MAI

CLASSIFICATION: 21 CFR Section 888.3030: Fastener, Fixation, Biodegradable, Soft Tissue

REVIEW PANEL: Orthopedics

#### INDICATIONS FOR USE

The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.

#### DEVICE DESCRIPTION

The Aesculap Resorbable Pin is a small orthopedic fixation pin made from a copolymer material (Poly-L,DL -Lactide Co70/30) that is absorbed into the body over time.

#### PURPOSE FOR SUBMISSION

The purpose for this submission is to gain marketing clearance for the Aesculap Resorbable Pin.

#### PERFORMANCE DATA

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device.

#### SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, Inc. believes that the Aesculap® Resorbable Pin is equivalent in materials and similar in use to the previously cleared Arthrex Meniscal Dart System (K983577) and the Bionx Smart Nail from ConMed Linvatec (K993074).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 3 0 2007

Aesculap® Implant Systems, Inc. % Mr. Matthew M. Hull Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K070178 Trade/Device Name: Aesulap® Resorbable Pin Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: January 19, 2007 Received: February 7, 2007

Dear Mr. Hull:

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 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 ed economic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Mr. Matthew M. Hull

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/industry/support/index.html.

Sincerely yours.

Barbara Buchner

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

Enclosure

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## B. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: Aesculap Resorbable Pin

Indication for Use:

(Per 21 CFR 801.109)

The Aesculap Resorbable Pin is intended for use in the fixation of fragments of non-load bearing bones, osteotomies, arthrodeses, meniscal tissue repair, and osteochondral repair.

| Prescription Use | <b>X</b> |
|-------------------------|----------|
| or Over-the-Counter Use | |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milhone

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

510(k) Number

(Optional Format 3-10-98)