ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)

K133950 · Bioretec, Ltd. · HTY · Jan 22, 2014 · Orthopedic

Device Facts

• Record ID: K133950
• Device Name: ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.)
• Applicant: Bioretec, Ltd.
• Product Code: HTY · Orthopedic
• Decision Date: Jan 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

Device Story

Bioabsorbable bone fixation pins/nails (ActivaPin/ActivaNail product group) used for orthopedic stabilization of fractures, osteotomies, and arthrodeses. Devices are manufactured from poly(L-lactide-co-glycolide) (PLGA); degrade in vivo via hydrolysis into alpha-hydroxy acids metabolized by the body. Maintain structural strength for at least 8 weeks; complete bioabsorption occurs within approximately two years, eliminating need for secondary removal surgery. ActivaPin HT modification features instrument-accepting holes at both ends to facilitate insertion. Devices are intended for use by surgeons in clinical settings. Output is physical bone fixation; clinical benefit is stabilization of bone segments during healing without permanent hardware.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bioabsorbable bone fixation pins/nails. Material: poly(L-lactide-co-glycolide) (PLGA). Dimensions: 1.5 mm diameter, 20-70 mm length. Mechanism: mechanical fixation via bioabsorbable polymer; degrades via hydrolysis. No software or electronic components.

Indications for Use

Indicated for fixation of bone fractures, osteotomies, arthrodeses, and osteochondral fractures requiring immobilization. Contraindicated for high-load bearing applications, active/potential infection, or cases where patient cooperation cannot be guaranteed.

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

• Bioretec ActivaPin (K061164)
• Bioretec ActivaPin Product Group (K080879)

Submission Summary (Full Text)

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K133950 (pg 1/3)

JAN 2 2 2014

# bioretec

#### Special 510(k) SUMMARY ਰ

For the modification to Bioretec ActivaPin™ Product Group

#### MANUFACTURER

Bioretec Ltd. Hermiankatu 22, Modulight Building F1-33720 Tampere FINLAND

#### Contact person:

Ms. Minna Räsänen Quality and Regulatory Affairs Manager Direct: [phone] Mobile: [phone] Fax: [phone] E-mail: Minna [e-mail]

Date prepared: December 19", 2013

#### DEVICE NAME

Bioretec ActivaPin™ Trade Name:

Bioretec ActivaPin™ Fusion

Bioretec ActivaNail ™ Conical

Bioretec ActivaNail™ Flat

Bioretec ActivaPin™ HT

Common Name: Pin, Fixation

#### DEVICE CLASSIFICATION AND PRODUCT CODE

Device Classification Name: Pin, Fixation, Smooth Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HTY

#### PREDICATE DEVICES

Bioretec ActivaPin™ (K061164), Bioretec ActivaPin™ Product Group (K080879)

Special 510(k) Date: December 19th, 2013

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#### DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION

The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.

Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.

The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.

The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.

The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.

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K133950 (pg 3/3)

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## EQUIVALENCE TO MARKETED PRODUCTS

The devices of modified Bioretec ActivaPin™ Product Group are substantially equivalent to the previously cleared Bioretec ActivaPin™ (K061164) and Bioretec ActivaPin™ Product Group (K080879).

The modified Bioretec ActivaPin™ products have the same intended use and principles of operation, and also the same technological characteristic and performance as the previously cleared Bioretec ActivaPin™ (K061164) and Bioretec ActivaPin ™ Product Group (K080879). Any differences between modified Bioretec ActivaPin™ products and predicate device do not raise any questions of safety and effectiveness.

## Special 510(k) Date: December 19th, 2013

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 22, 2014

Bioretec Limited Ms. Minna Räsänen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere Finland

Re: K133950

Trade/Device Name: ActivaPin™ Product Group (ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat, ActivaPin™ HT) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: December 19, 2013 Received: December 23, 2013

Dear Ms. Räsänen:

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

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#### Page 2 - Ms. Minna Räsänen

.

device-related adverse events) (21 CFR 803); 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.

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" (21 CFR 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.

# Ronald##Jean -S for

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

Enclosure

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bioretec

#### F Indications for Use Statement

| Submitter: | Bioretec Ltd. |
|----------------|--------------------------|
| 510(k) Number: | K133950 |
| Device Name: | ActivaPin™ Product Group |
| | ActivaPin™ |
| | ActivaPin™ Fusion |
| | ActivaNail™ Conical |
| | ActivaNail™ Flat |
| | ActivaPin™ HT |

#### Indications for Use:

The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.

#### Contraindications:

..

1. High-load bearing applications

2. Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient's co-operation cannot be guaranteed.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

.

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Orthopedic Devices