(57 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI or ML.
Yes
The device is a two-piece clamping device intended for stabilization and fixation of anterior chest wall fractures, including the sternum, which describes a therapeutic function.
No
The device is intended for stabilization and fixation of fractures, not for diagnosing medical conditions.
No
The device description clearly describes a physical, two-piece clamping device with plates, screws, and a ratcheted locking system, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details a mechanical clamping device with plates and screws designed to physically hold bone fragments together. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical tool and implant used for mechanical fixation within the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, sternum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KLS Martin Sternal Talon (K051165, K070169), Synthes Sternal Fixation System - Modification to Surgical Technique (K093772)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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.
1
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).
2
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
3
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
4
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)