PROTOE ENDOSORB SMALL HAMMER TOE PIN

K100414 · Merete Medical GmbH · JDW · Jul 2, 2010 · Orthopedic

Device Facts

• Record ID: K100414
• Device Name: PROTOE ENDOSORB SMALL HAMMER TOE PIN
• Applicant: Merete Medical GmbH
• Product Code: JDW · Orthopedic
• Decision Date: Jul 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.

Device Story

ProToe™ EndoSorb™ Small Hammer Toe Pin is a bioresorbable fixation device for proximal interphalangeal (PIP) joint arthrodesis. Constructed from EndoSorb™, a poly(L-lactide-co-glycolide) (PLGA) polyester derivative, the pin features threads on one end and barbs on the other to secure bone segments. The device is implanted by a surgeon to facilitate joint fusion; it degrades in vivo via hydrolysis into L-lactic and glycolic acids, which are subsequently metabolized by the body. This eliminates the need for secondary removal surgery associated with permanent metallic implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Bioresorbable poly(L-lactide-co-glycolide) (PLGA). Design: Pin with threads on one side and barbs on the other. Function: Bone fixation/arthrodesis. Mechanism: Degradation via in vivo hydrolysis.

Indications for Use

Indicated for patients requiring proximal interphalangeal (PIP) joint arthrodesis.

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

• Small Hammer Toe Pin, Biomet, Inc. (K021828)
• Resorbable Hammertoe Pin, Biomet. Inc. (K011137)

Submission Summary (Full Text)

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K100414

Submission Date: 09.02.2010

| 2 510(k) Summary | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------|
| Submitted by: | Merete Medical GmbH<br>Alt Lankwitz 102<br>12247 Berlin, Germany |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Emmanuel Anapliotis<br>Merete Medical, Inc.<br>49 Purchase Street<br>Rye, New York 10580<br>Phone: [phone] |
| Proprietary Name: | ProToe™ EndoSorb™ Small Hammer Toe Pin |
| Common Name: | Arthrodesis Pin |
| Device Classification: | Screw, Fixation, Bone, Non-spinal, non-metallic<br>(888.3040) |
| Product Code: | HWC |

Proposed Regulatory Class: Class II

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Small Hammer Toe Pin, Biomet, Inc. (K021828); Resorbable Hammertoe Pin, Biomet. Inc. (K011137)

#### Intended Use:

The ProToe™ EndoSorb™ Small Hammer Toe Pin is indicated for proximal interphalangeal (PIP) joint arthrodesis.

### Device Description:

The ProToe™ EndoSorb™ Small Hammer Toe Pin is made out of the bioresorbable EndoSorb™ material and is indicated for proximal interphalangeal (PIP) joint arthrodesis. EndoSorb™ is a polyerster derivative of L-Lactic and glycolic acids. Poly(L-lactide-co-glycolide) material (PLGA) degrades and resorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the body. The device has threads on one side and barbs on the other.

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#### 510(k) Submission - ProToe™ EndoSorb™ Small Hammer Toe Pin

# Substantial Equivalence:

The ProToe™ EndoSorb™ Small Hammer Toe Pin is similar to legally marketed predicate device listed above in that it shares similar indications for use, is manufactured from similar materials and incorporate similar technological characteristics. Any differences have been found to have no obvious effect on the performance, function, or intended use of the prosthesis.

### Software Documentation:

No software is needed for the use of this device.

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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 consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

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

Merete Medical GmbH % Merete Medical, Inc. Mr. Emmanuel Anapliotis 49 Purchase Street Rye, New York 10580

**JUL.-2 2010**

Re: K100414

Trade/Device Name: ProToe™ EndoSorb™ Small Hammer Toe Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW, HWC Dated: June 25, 2010 Received: June 28, 2010

Dear Mr. Anapliotis:

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 - Mr. Emmanuel Anapliotis

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Barbara Buehrig

Mark N. Me son Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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p. '1/1

Submission Date: 09.02.2010

#### Indications for Use Statement 1

# Indications for Use

510(k) Number (if known):

Device Name: ProToe™ EndoSorb™ Small Hammer Toe Pin

Indications for Use:

The ProToe™ EndoSorb™ Small Hammer Toe Pln is indicated for proximal interphalangeal (PIP) joint arthrodesis.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Merete Medical GmbH · Alt Lankwitz 102 · 12247 Berlin, Germany · Phone: +49 (0)30 / 77 99 80-0 US Agent: Merete Medical, Inc. • 49 Purchase Street • Rye, N.Y. 10580 • Phone: 914 • 067-1552

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