KLS MARTIN RECON TALON

K122860 · KLS Martin L.P. · HRS · Nov 14, 2012 · Orthopedic

Device Facts

• Record ID: K122860
• Device Name: KLS MARTIN RECON TALON
• Applicant: KLS Martin L.P.
• Product Code: HRS · Orthopedic
• Decision Date: Nov 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

Device Story

Recon Talon is a two-piece bone fixation appliance featuring attached plates and a ratcheted locking system. Device components are affixed to opposing sides of the sternum; interlock to provide stabilized fixation. Features three-position screw (open, close, lock) for securement and emergency re-entry; includes cut points for secondary emergency removal. Plate thickness: 1.0-3.0 mm; screw diameter: 2.3-3.2 mm. Used by surgeons in clinical settings for chest wall stabilization. Provides mechanical fixation to support bone healing.

Clinical Evidence

Bench testing only. Fatigue testing (75 N for 5 million cycles) showed no failures. Tensile testing to failure reached 1.06 kN. System testing using Sawbones in transverse, longitudinal, and lateral shear modes yielded 0.92 kN, 1.23 kN, and 1.65 kN respectively. No device failures occurred during system testing; failure modes were limited to screw/Sawbone interface pullout or Sawbone failure.

Technological Characteristics

Material: TI-6AL-4V. Plate thickness: 1.0-3.0 mm. Screw diameter: 2.3-3.2 mm. Mechanism: Ratcheted locking system with three-position screw. Sterilization: Provided sterile per ISO 11137-1, -2. Packaging validated to ISO 11607-1, -2.

Indications for Use

Indicated for stabilization and fixation of anterior chest wall fractures, including sternal fixation following sternotomy and sternal reconstructive procedures.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• KLS Martin Sternal Talon (K051165, K070169)
• Synthes Sternal Fixation System - Modification to Surgical Technique (K093772)

Submission Summary (Full Text)

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is martin L.

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 · Fax [phone] www.klsmartin.com

# X122860

510(k) Summary Section 21 CFR 807.92

NOV 1 4 2012

Submitter:

Contact Person:

KLS Martin, L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246

Jennifer Damato Director of Quality Mgt. and Regulatory Affairs Phone: [phone] Fax: [phone]

Date Prepared:

Recon Talon

November 1, 2012

Bone Fixation Appliance

Bone Fixation Plate

Trade Name:

Common Name:

Classification:

Class II, 21 CFR 888.3030, Product Code HRS

Predicate Devices:

KLS Martin Sternal Talon (K051165, K070169) Synthes Sternal Fixation System - Modification to Surgical Technique (K093772)

#### Device Description:

The KLS Martin Recon Talon is a two-piece clamping device, which has on either end an attached plate. Plate thickness ranges from 1.0 mm to 3.0 mm and screw diameter ranges from 2.3 mm to 3.2 mm. The two-piece clamping device utilizes a ratcheted locking system. Each piece of the device is affixed to opposing sides of the sternum and interlocks to provide stabilized fixation. The device has a three position screw, allowing the ratchet to open, close, and lock. In an emergency situation the device can be reopened by turning the screw to the open position. Secondary emergency re-entry is provided by cut points adjacent to the screw.

#### Indications for Use:

The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

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# 1122860

Image /page/1/Picture/1 description: The image shows the text "KLS martin LP." in a stylized font. The letters "KLS" and "LP" are in solid black, while the letters "martin" are outlined in black with a white fill. The text appears to be a logo or brand name.

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 · Fax [phone] www.kIsmartin.com

### Technological Characteristics:

| Characteristic | Recon Talon | Sternal Talon (K051165 & K070169) | Synthes Sternal Fixation System (K093772) |
|-------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------|-------------------------------------------------------------|
| Material | TI-6AL-4V | TI-6AL-4V or CP Titanium | Titanium (grade unknown) |
| Plate Thickness | 1.0 - 3.0 mm | N/A | 2.4 mm |
| Screw Diameter | 2.3 - 3.2 mm | N/A | 3.0 mm |
| Sterility | Provided sterile | Provided sterile & non-sterile | Provided non-sterile |
| Method of Closure | Orthopedic fixation using a positive locking system incorporating titanium plates and screws | Orthopedic fixation using a positive locking system | Orthopedic fixation using a titanium plate and screw system |

#### Similarities to Predicates

The Recon Talon utilizes the same ratcheted locking system as the Sternal Talon (K051165, K070169) and incorporates rib-to-rib fixation plates affixed with titanium screws similar to those included in the Synthes Sternal Fixation System (K093772). Placement and fixation of the Recon Talon is similar to the method used for the Synthes Sternal Fixation System (K093772).

#### Differences to Predicates

The Recon Talon design incorporates characteristics from the KLS Martin Sternal Talon (K01165, K070169) and the Synthes Sternal Fixation System (K093772).

#### Performance Testing:

Three different modes were evaluated in separate performance tests. Fatigue testing was performed on individual Recon Talons using 75 N for 5 million cycles with no device failures. Tensile tests were also performed on individual Recon Talons to failure where the maximum load was 1.06 kN. System testing was conducted using Sawbones in 3 loading modes: transverse, longitudinal and lateral shear. The results were 0.92, 1.23, and 1.65 kN respectively. Method of failure in all system testing was either pullout at the screw/Sawbone interface or Sawbone failure. No device failures were noted in system testing. Results met the defined test conditions and demonstrate safety and effectiveness. Packaging and sterilization validation to ISO 11607-1, -2 and ISO.11137-1, -2 demonstrate conformance to the standards tested.

#### Conclusion:

Performance testing results demonstrate that the Recon Talon is substantially equivalent to the KLS Martin Sternal Talon (K051165, K070169). In addition, similarities in the technological characteristics support substantial equivalence to the KLS Martin Sternal Talon (K051165, K070169) and the Synthes Sternal Fixation System (K093772).

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

Letter Dated: November 14, 2012

KLS Martin L.P. % Ms. Jennifer Damato Director of Quality Management and Regulatory Affairs 11201 Saint Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K122860 Trade/Device Name: Recon Talon Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: Sept. 11, 2012 Received: Sept. 18, 2012

Dear Ms. Damato:

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

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#### Page 2-Ms. Jennifer Damato

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,

### Laurence D. Coyne

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

Enclosure

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## Indications for Use

# SECTION 4

| 510(k) Number (if known): | K122860 |
|---------------------------|-------------|
| Device Name: | Recon Talon |

#### Indications for Use:

The KLS Martin Recon Talon is intended for use in stabilization and fixation of anterior The RED Martin Room including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

> Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number k122860

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Recon Talon 510(k)