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 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.

AI/ML Overview

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

Here's an analysis of the provided information regarding its acceptance criteria and the study proving it:

1. Table of Acceptance Criteria and Reported Device Performance

Test Mode	Acceptance Criteria (Implied)	Reported Device Performance
Fatigue Testing	No device failures after 5 million cycles using 75 N.	No device failures recorded.
Tensile Testing	Device withstands a significant load before failure.	Maximum load at failure: 1.06 kN.
System Testing (Sawbones)	No device failures; failure primarily at Sawbone interface.	Transverse: 0.92 kN (Sawbone failure/pullout) Longitudinal: 1.23 kN (Sawbone failure/pullout) Lateral Shear: 1.65 kN (Sawbone failure/pullout)
Packaging & Sterilization	Conformance to ISO 11607-1, -2 and ISO 11137-1, -2 standards.	Conformance demonstrated.

Note: The acceptance criteria are largely implied by the reporting structure of the performance testing results. For instance, for fatigue testing, "no device failures" is the explicit outcome that validates the device meets an inherent requirement for durability. Similarly, for system testing, the phrase "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" indicates that the device itself did not fail, meeting the intended performance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for each test. The wording "individual Recon Talons" for fatigue and tensile tests, and "Sawbones" for system testing, suggests multiple units/specimens were used, but the exact number isn't quantified.
Data Provenance: The studies were conducted by KLS Martin, L.P. The type of study is prospective, laboratory-based physical testing of the device. The data is from in-vitro testing using mechanical forces and Sawbones, not from human or animal subjects, so country of origin of patient data is not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. The "ground truth" for this device is based on engineering performance specifications and objective physical measurements rather than expert interpretation of medical images or clinical outcomes. The tests evaluate the mechanical integrity and strength of the device itself.

4. Adjudication Method for the Test Set

Not applicable. This involves objective physical testing with measurable outcomes (e.g., force at failure, number of cycles without failure), which typically does not require expert adjudication in the same way clinical data or image interpretation would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for diagnostic devices that involve human interpretation of outputs (e.g., radiologists reading images with or without AI assistance). The Recon Talon is a physical orthopedic implant, and its performance is evaluated through mechanical testing, not human reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, effectively. The performance testing described (fatigue, tensile, system testing) evaluates the device's inherent mechanical properties and behavior directly, without human intervention during the test itself. While humans set up and observe the tests, the performance criteria are machine-measured and objective.

7. The Type of Ground Truth Used

The ground truth is based on engineering specifications and established mechanical testing protocols. For example, "no device failures after 5 million cycles" is the ground truth for fatigue performance. "Maximum load was 1.06 kN" is the ground truth for tensile strength. These are objective, quantitative measures of the physical device's performance.

8. The Sample Size for the Training Set

Not applicable. The Recon Talon is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development. The design and manufacturing processes are iterative but do not involve 'training' in this sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a physical medical device, the concept of a training set and its associated ground truth establishment does not apply. Performance is validated through the tests described in point 1.

Summary

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is martin L.

P.O. Box 16369 · Jacksonville, FL 32245-6369 904-641-7746 or 800-625-1557 · Fax 904-641-7378 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: 800-625-1557 Fax: 904-641-7378

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:

Indications for Use:

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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 904-641-7378 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 (800) 638-2041 or (301) 796-7100 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)

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
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.(b)
Classification. Class II.