TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND

K102298 · Depuy Mitek, A Johnson & Johnson Company · HWC · Jan 7, 2011 · Orthopedic

Device Facts

• Record ID: K102298
• Device Name: TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND
• Applicant: Depuy Mitek, A Johnson & Johnson Company
• Product Code: HWC · Orthopedic
• Decision Date: Jan 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with postoperative immobilization as follows: [Table of indications for Shoulder, Foot/Ankle, Knee, Elbow, Wrist, and Hip procedures provided].

Device Story

TransTend Anchors are suture anchors used for soft tissue-to-bone fixation. The device consists of an anchor (available in Biocryl Rapide, Titanium, or PEEK) preloaded on a disposable inserter assembly, intended for use with #2 suture. The device is used by surgeons in an operating room setting to secure soft tissue to bone during orthopedic procedures. The anchor is implanted into bone to provide a secure attachment point for sutures, which are then used to reattach or stabilize soft tissue. This fixation facilitates healing during the post-operative immobilization period. The device is provided sterile for single-patient use.

Clinical Evidence

No clinical data. Bench testing only. Verification activities included pull-out testing, insertion torque testing, sterilization validation, and biocompatibility testing to demonstrate safety and performance equivalence to predicate devices.

Technological Characteristics

Suture anchors available in 2.9 mm (Titanium) and 3.4 mm (Biocryl Rapide, PEEK) diameters. Materials: Biocryl Rapide, Titanium, or PEEK. Supplied sterile for single-use. Includes disposable inserter assembly and optional cannula assembly. Mechanical fixation principle.

Indications for Use

Indicated for soft tissue to bone fixation in patients requiring surgical repair of rotator cuff, biceps tenodesis, acromio-clavicular separation, deltoid repair, lateral/medial stabilization, mid-foot reconstruction, hallux valgus repair, metatarsal ligament/tendon repairs, collateral ligament repairs (knee), iliotibial band tenodesis, lateral epicondylitis repair, scapholunate ligament reconstruction, capsular repair, and acetabular labral repair.

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

• Gryphon Br - Hip (K100012)
• Gryphon P BR Anchor (K090124)
• Gryphon BR / Healix BR Anchors (K073412)
• Healix Ti Anchor (K082282)
• Healix Peek Anchor (K071481)
• Arthrex BioComposite Corkscrew Anchor (K082810)
• KFX Suture lock Nail Bone Anchor (K081598)
• Twin Fix Ti Quick T 3.5 mm Fixation System (K020159)

Submission Summary (Full Text)

{0}------------------------------------------------

K102298
p. 1 of 2

## 510(k) SUMMARY

## TransTend Anchors

JAN - 7 2011

| Submitter's Name<br>and Address: | DePuy Mitek<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767 |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo<br>Regulatory Affairs Project Manager<br>DePuy Mitek, Inc.<br>a Johnson & Johnson company<br>325 Paramount Drive<br>Raynham, MA 02767, USA<br>Telephone: [phone]<br>Facsimile: 508-977-6955<br>e-mail: [e-mail]<br>Prepared 10/30/2010 |
| Name of Medical<br>Device | Classification Name: Single/multiple component metallic bone fixation<br>appliances and accessories |
| | Common/Usual Name: Bone Anchor |
| | Proprietary Name: TransTend Anchors |
| Substantial<br>Equivalence | The proposed TransTend Anchors are substantially equivalent to:<br>K100012 Gryphon Br - Hip (March 10, 2010) K090124 Gryphon P BR Anchor (March 11, 2009) K073412 Gryphon BR / Healix BR Anchors (January 17, 2008) K082282 Healix Ti Anchor (November 7, 2008) K071481 Healix Peek Anchor (August 9, 2007) K082810 Arthrex BioComposite Corkscrew Anchor (January 23, 2009) K081598 KFX Suture lock Nail Bone Anchor (July 3, 2008) K020159 Twin Fix Ti Quick T 3.5 mm Fixation System ( March 26, 2010) |
| Device<br>Classification | These devices carry an FDA product code HWC, and subsequent codes MBI and<br>MAI, regulated under 21 CFR 888.3040 and 21 CFR 888.3030. |
| | The proposed TransTend Anchors are suture anchors offered in three different |

{1}------------------------------------------------

K102298
p. 2012

### Device Description

materials, namely Biocryl Rapide, Titanium or Peek. The anchor comes preloaded on a disposable inserter assembly and is intended for fixation of size #2 suture to bone. The suture option is provided without needles. The TransTend Anchors are provided as size 3.4 mm in Biocryl Rapide, 3.4mm in Peek and 2.9 mm in Titanium. Each TransTend Anchor is provided sterile and is for single patient use only. The TranTend anchors will also be offered in a convenience kit and be packaged with a cannula assembly along with one or two TransTend Anchor(s).

Technologies characteristics including material for design, and packaging are the same as the predicates cleared devices.

The TransTend Anchor is indicated for use in soft tissue to bone fixation in Indications for association with post-operative immobilization as follows: Use

| | Indication | BR | PEEK | Titanium |
|------------|--------------------------------------|----|------|----------|
| Shoulder | Rotator Cuff | X | X | X |
| | Partial Thickness Rotator Cuff | X | X | X |
| | Biceps Tenodesis | | X | X |
| | Acromio-Clavicular Separation | | X | X |
| | Deltoid Repair | | X | X |
| Foot/Ankle | Lateral Stabilization | | X | X |
| | Medial Stabilization | | X | X |
| | Mid-foot Reconstruction | | X | X |
| | Hallux Valgus Repair | | X | X |
| | Metatarsal Ligament/Tendon Repairs | | X | X |
| Knee | Medial Collateral Ligament Repair | | X | X |
| | Lateral Collateral Ligament Repair | | X | X |
| | Posterior Oblique Ligament Repair | | X | X |
| | Iliotibial Band Tenodesis | | X | X |
| Elbow | Lateral Epicondylitis Repair | | X | X |
| Wrist | Scapholunate Ligament Reconstruction | | X | X |
| Hip | Capsular Repair | | X | X |
| | Acetabular Labral Repair | | X | X |

### Non clinical Testing

Verification activities were performed on the implant or its predicates. Testing includes pull out testing, insertion torque testing, sterilization and biocompatibility.

Results of performance and safety testing have demonstrated that the proposed Safety and devices are suitable for their intended use. Performance

> Based on the indications for use, technological characteristics, and comparison to the predicate devices, the proposed TransTend Anchors Anchor (s) have shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is presented in black and white.

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

DePuy Mitek, Inc. % Ms. Kristine Christo Regulatory Affairs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767

JAN - 7 2011

Re: K102298

Trade/Device Name: TransTend (BR, Ti, Peek) Anchors Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, MAI Dated: December 30, 2010 Received: January 03, 2011

Dear Ms. Christo:

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

{3}------------------------------------------------

Page 2 - Ms. Kristine Christo

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For Peter Dunn

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

Enclosure

{4}------------------------------------------------

K102298

# Indications for Use

510(k) Number (if known): K102298

JAN - 7 2011

· Device Name: TransTend (BR, Ti, Peek) Anchors

The TransTend Anchor is indicated for use in soft tissue to bone fixation in association with postoperative immobilization as follows:

| | Indication | BR | PEEK | Titanium |
|------------|--------------------------------------|----|------|----------|
| Shoulder | Rotator Cuff | X | X | X |
| | Partial Thickness Rotator Cuff | X | X | X |
| | Biceps Tenodesis | | X | X |
| | Acromio-Clavicular Separation | | X | X |
| | Deltoid Repair | | X | X |
| Foot/Ankle | Lateral Stabilization | | X | X |
| | Medial Stabilization | | X | X |
| | Mid-foot Reconstruction | | X | X |
| | Hallux Valgus Repair | | X | X |
| | Metatarsal Ligament/Tendon Repairs | | X | X |
| Knee | Medial Collateral Ligament Repair | | X | X |
| | Lateral Collateral Ligament Repair | | X | X |
| | Posterior Oblique Ligament Repair | | X | X |
| | Iliotibial Band Tenodesis | | X | X |
| Elbow | Lateral Epicondylitis Repair | | X | X |
| Wrist | Scapholunate Ligament Reconstruction | | X | X |
| Hip | Capsular Repair | | X | X |
| | Acetabular Labral Repair | | X | X |

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)

Page 1 of_1

for M.Mdkerrm
(Division Sign Off)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102298