TWISTCUT ENDOSORB SCREWS

K102777 · Merete Medical GmbH · JDW · Dec 20, 2010 · Orthopedic

Device Facts

• Record ID: K102777
• Device Name: TWISTCUT ENDOSORB SCREWS
• Applicant: Merete Medical GmbH
• Product Code: JDW · Orthopedic
• Decision Date: Dec 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TwistCut™ EndoSorb™ Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures: - 1. for metacarpal and phalangeal fusion and fracture - 2. or repair of hallux valgus deformity (bunion).

Device Story

TwistCut™ EndoSorb™ Bone Screws are absorbable orthopedic fixation devices. Manufactured from EndoSorb™ (polyester derivative of L-Lactic and glycolic acids/PLGA); material degrades in vivo via hydrolysis into L-lactic and glycolic acids. Features hexagonal twist-off head portion to ensure flush seating with bone surface. Used by surgeons in clinical settings for metacarpal/phalangeal fusion/fracture and hallux valgus repair. Device provides mechanical stabilization during bone healing; absorbs over time, eliminating need for secondary removal surgery.

Clinical Evidence

Bench testing only. Tests included in vitro degradation (strength/viscosity), inherent viscosity, glass transition temperature, crystallinity, breakage strength, insertion torque, and long-term/transport stability.

Technological Characteristics

Material: EndoSorb™ (PLGA - poly(L-lactide-co-glycolide)). Principle: Absorbable bone fixation fastener. Form factor: Screw with hexagonal twist-off head. Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for metacarpal and phalangeal fusion and fracture, and repair of hallux valgus deformity (bunion) in patients requiring bone fixation with appropriate immobilization.

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

• ProToe™ EndoSorb™ Small Hammer Toe Pin, Merete (K100414)
• Reunite Screws, Biomet (K992301)

Submission Summary (Full Text)

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Submission Date: 08 / 24 / 2010

2. 510(k) SUMMARY

K102777
pg 1/2

| | DEC 20 2010 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------|
| 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: | TwistCut ^TM EndoSorb ^TM Screws |
| Device Classification: | Smooth or threaded metallic bone fixation<br>Fastener (888.3040) |
| Product Code: | JDW |
| Subsequent Product Code: | HWC |
| Proposed Regulatory Class: | Class II |

# Legally Marketed Devices To Which Substantial Equivalence is Claimed:

ProToe™ EndoSorb™ Small Hammer Toe Pin, Merete (K100414) Reunite Screws, Biomet (K992301)

### Intended Use:

The TwistCut™ EndoSorb™ Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures:

- 1. for metacarpal and phalangeal fusion and fracture
- 2. or repair of hallux valgus deformity (bunion).

### Device Description:

The TwistCut™ EndoSorb™ Bone Screws are made out of the absorbable EndoSorb™ material. EndoSorb™ is a polyester derivative of L-Lactic and glycolic acids.

Poly(L-lactide-co-dlycolide) material (PLGA) degrades and absorbs in vivo by hydrolysis into L-lactic and glycolic acids, which are then metabolized by the screw head provides a hexagonal twist off portion to enable screw head to be flush with the bone.

Merete Medical GmbH

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Submission Date: 08 / 24 / 2010

# Substantial Equivalence:

The TwistCut™ EndoSorb™ Bone Screws 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.

The following bench tests were performed:

- . In vitro degradation test (determination of decreasing strength and inherent viscosity)
- Determination of inherent viscosity, glass transition temperature and crystallinity .
- . Brakeage strength and insertions torque
- Long-term stability of package and subject device .
- . Stability test under extreme transport conditions
- Temperature limit for storage .
- A geometrical and a material comparison of the subject and the predicate devices were . provided. This information served as a basis for a determination of substantial equivalence.

The predicates for the subject device are ProToe™ EndoSorb™ Small Hammer Toe Pin, Merete (K100414); Reunite Screws, Biomet (K992301).

# Software Documentation:

No software is needed for the use of this device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services-USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

Merete Medical GmbH % Mr. Emmanuel Anapliotis President & CEO Alt Lankwitz 102 12247 Berlin, Germany

DEC 2 0 2010

Re: K102777

Trade/Device Name: TwistCut EndoSorb Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: JDW, HWC Dated: September 21, 2010 Received: September 24, 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. Ilsting 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 (OS) 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/ReportalProblem/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 vours.

Sincerely yours,

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

Enclosure

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Submission Date: 08 / 24 / 2010

#### 1. INDICATIONS FOR USE STATEMENT

FDA CDRH DMC

SEP 24 2010

Received

# Indications for Use

10.27777 510(k) Number (if known):

DEC 2 0 7010

Device Name: TwistCut™ EndoSorb™ Bone Screw

.

Indications for Use:

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The TwistCut™ EndoSorb™ Bone Screws are indicated for use in the presence of appropriate immobilization in the following procedures:

- 1. for metacarpal and phalangeal fusion and fracture
- 2. or repair of hallux valgus deformity (bunion).

\$\gamma\$

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) | for M. Melkeren |
|--------------------------------------------------------|-----------------------------------------------------------|
| | (Division Sign-Off) |
| | Division of Surgical, Orthopedic, and Restorative Devices |

| Merete Medical GmbH | prepared 08/24/2010 |
|---------------------|---------------------|
| | Page 4 of 28. |
| 510(k) Number | K102777 |