LIFENET SYSTEM

K093925 · Physio-Control, Inc. · MSX · Jan 12, 2010 · Cardiovascular

Device Facts

• Record ID: K093925
• Device Name: LIFENET SYSTEM
• Applicant: Physio-Control, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Jan 12, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromioclavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction. Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair. Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illiotibial band tenodesis. Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction. Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

Device Story

The FOOTPRINT RCX PK Suture Anchor is a screw-in, PEEK polymer anchor used in arthroscopic surgery. It is loaded with up to four suture strands to secure soft tissue to bone. Operated by surgeons in an OR setting, the device allows intraoperative tension adjustment of the tissue. It facilitates repair of various orthopedic injuries, including rotator cuff, ligament, and tendon reconstructions, potentially improving patient recovery through stable fixation.

Clinical Evidence

Bench testing only. Performance testing demonstrated that insertion and fixation properties are substantially equivalent to the predicate device.

Technological Characteristics

Material: PEEK polymer. Form factor: Screw-in suture anchor. Capacity: Up to four suture strands. Function: Soft tissue to bone fixation.

Indications for Use

Indicated for reattachment of soft tissue to bone in shoulder, foot/ankle, knee, hand/wrist, and elbow procedures, including ligament, tendon, and capsular repairs/reconstructions.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Smith & Nephew Twinfix PK FP Suture Anchor (K073509)

Submission Summary (Full Text)

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# SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

## Smith & Nephew FOOTPRINT RCX PK Suture Anchor

Date Prepared: December 18, 2007

### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810

### B. Company Contact

Christina Flores Regulatory Affairs Specialist II [phone] Phone: FAX: [phone]

#### C. Device Name

Trade Name: FOOTPRINT RCX PK Suture Anchor Common Name: Suture Anchor Classification Name: Fastener, fixation, non-degradable, soft tissue

#### D. Predicate Devices

The Smith & Nephew FOOTPRINT RCX PK Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Twinfix PK FP Suture Anchor.

#### E. Description of Device

The FOOTPRINT RCX PK Suture Anchor is a suture anchor manufactured from PEEK polymer. The screw-in anchor can be loaded with up to four strands of suture and facilitates arthroscopic repair of soft tissue to bone. The design allows

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#### K093935p.20f 2

the surgeon to adjust the tension on the tissue intraoperatively and secure the repair.

#### F. Intended Use

The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromioclavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illiotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction

### G. Comparison of Technological Characteristics

The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is substantially equivalent in materials, fundamental scientific technology, and intended use and is as safe and effective as its currently marketed predicate device, the Smith & Nephew Twinfix PK FP (K073509).

## H. Summary Performance Data

The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew FOOTPRINT RCX PK suture anchor is substantially equivalent to the predicate Smith & Nephew Twinfix PK FP suture anchor, cleared via K073509. The testing also demonstrates the new device does not raise any new issues of safety and efficacy.

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

Smith & Nephew, Inc. % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810

APR - 6 2010

Re: K093935

Trade/Device Name: Smith & Nephew FOOTPRINT RCX PK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 26, 2010 Received: March 29, 2010

Dear Ms. Flores:

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 iddications 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 Amendmants, or to devices that have been reclassified in accordance with the provisions of the Federal Foond, Or re 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 Trich, general controls provisions of the Act include requirements for annual registration, institus of devices, good manufacturing practice, labeling, and prohibitions against misbrandijing 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 after in ground (in the can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, UDA 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. Your 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

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#### Page 2 - Ms. Christina Flores

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/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 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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#### Indications for Use

Kod 3935 510(k) Number (if known):

Device Name: Smith & Nephew FOOTPRINT RCX PK Suture Anchor

Indications For Use:

The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.

Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.

Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Illiotibial band tenodesis.

Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.

Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Surgical, Orthopedic, and Restorative Devices

| 510(k) Number | K093935 |
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