(82 days)
The KLS Martin Mandibular / Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
KLS-Martin Mandibular Fracture / Reconstruction II includes several different designs of titanium plates and screws. New plates added to system are angled and precurved to follow the natural curves of the Mandible. Changes to this fracture / reconstruction system are not functionally different and could typically be addressed with letter to file for predicate 510(k)s. This 510(k) ensures plates and screws listed have current 510(k)s. KLS Martin Mandibular / Reconstruction System II is intended for use in stabilization and fixation of Mandibular Fractures and Reconstruction.
The provided document is a 510(k) summary for a medical device (KLS Martin Mandibular / Reconstruction System II) and a FDA clearance letter. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of document is about demonstrating substantial equivalence to predicate devices, not about detailed performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
Here's why and what kind of information is missing:
- Acceptance Criteria & Reported Performance: This document states the intended use and technological characteristics, comparing them to predicate devices. It does not set forth specific, quantifiable acceptance criteria (e.g., "flexural strength must be X MPa") or report specific device performance results (e.g., "flexural strength achieved Y MPa").
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all aspects of a detailed study to evaluate a device's performance, especially for algorithms or diagnostic tools. This document is for a physical medical device (plates and screws) and primarily relies on demonstrating substantial equivalence to existing devices through similar design, materials, and intended use, rather than a clinical trial or algorithm performance study.
In the context of 510(k) submissions for physical devices like bone plates, "acceptance criteria" are usually related to established material properties (e.g., tensile strength, fatigue life) or mechanical tests performed to ensure the device performs as intended and is comparable to predicate devices. The document mentions "comparison of performance" and "similarity of materials" as bases for substantial equivalence, implying such tests would have been done, but it doesn't describe them or their results in detail.
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OCT 2 9 2003
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· Jacksonville, FL 32250-0249 or 1-800-625-1557 • Fax 904-641-7378
510(k) SUMMARY
Submitter of 510(k):
KLS Martin L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246 Phone: 904-641-7746 Fax: 904-641-7378
Contact Person:
Summary Date:
Device Name:
Trade Name:
Common Name:
Classification Name and Number:
Regulatory Class:
Predicate Devices:
27 June 2003
Jennifer Damato Director RA/QA
KLS Martin Mandibular / Reconstruction System II
Mandibular / Reconstruction System II
Plate, Bone
Plate, Bone (CFR 872.4760)
Class II
Synthes Universal 2.4mm Locking Plate System (K961421)
Synthes 2.0 Locking Plate System (K974555)
KLS-Martin Mandibular / Reconstruction System (K950045)
KLS Mini Osteosynthesis System (K943347)
OSTEOMED 2.0 Locking Plates and Screws (K030448)
KLS-Martin Temporary Condylar Implant (K990667)
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Image /page/1/Picture/0 description: The image shows the logo for KLS Martin L.P. The logo consists of the letters "KLS" inside of a circle, which is inside of a shield. To the right of the shield is the word "martin" in a box, followed by "L.P." The logo is black and white.
.O. Box 50249 • Jacksonville, FL 32250-0249 4-641-7746 or 1-800-625-1557 ● Fax 904-641-7378 www.klsmartin.com
Device Description:
KLS-Martin Mandibular Fracture / Reconstruction II includes several different designs of titanium plates and screws. New plates added to system are angled and precurved to follow the natural curves of the Mandible.
Changes to this fracture / reconstruction system are not functionally different and could typically be addressed with letter to file for predicate 510(k)s. This 510(k) ensures plates and screws listed have current 510(k)s.
KLS Martin Mandibular / Reconstruction System II is
Fractures and Reconstruction.
intended for use in stabilization and fixation of Mandibular
Intended Use:
Technological Characteristics:
Similarities to Predicate
Changes to this fracture / reconstruction system are not functionally different and could typically be addressed with letter to file for predicate 510(k)s. This 510(k) ensures plates and screws listed have current 510(k)s.
Plates and screws are similar to Synthes Universal 2.4mm Locking Plate System (K961421), Synthes 2.0 Locking Plate System (974555), KLS-Martin Mandibular / Reconstruction System (K950045), KLS Mini Osteosynthesis System (K943347), OSTEOMED 2.0 Locking Plates and Screws (K030448), and KLS-Martin Temporary Condylar Implant (K990667).
Screws are offered in diameter from 2.0mm to 3.2mm, lengths of 8mm through 22mm, and are available in standard or locking threads. Plates vary in thickness and are available as non-compression, compression, and threaded types.
Plates and screws are either commercially pure (CP) Titanium or Ti-6AL-4V Titanium Alloy.
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Image /page/2/Picture/0 description: The image shows the logo for KLS Martin L.P. The logo consists of the letters "KLS" inside of a triangle with a circle inside of it. To the right of that is the word "martin" with the letter "m" inside of a square, and the letters "L.P." to the right of that.
P.O. Box 50249 · Jacksonville, FL 32250-0249 904-641-7746 or 1-800-625-1557 • Fax 904-641-7378 www.klsmartin.com
Plates and screw designs are of similar shape and size of competitive products for Mandibular Fracture and Reconstruction.
Differences to Predicate
New plates added to system are angled and pre-curved to follow the natural curves of the Mandible.
The new plates do not represent a major modification to system.
Substantial Equivalence:
The KLS-Martin Mandibular / Reconstructive System II is substantially equivalent in application and function to the Synthes Universal 2.4mm Locking Plate System (K961421), Synthes 2.0 Locking Plate System (K974555), KLS-Martin Mandibular / Reconstruction System (K950045), KLS Mini Osteosynthesis System (K943347), OSTEOMED 2.0 Locking Plates and Screws (K030448), and KLS-Martin Temporary Condylar Implant (K990667).
Substantial equivalence is based on comparison of performance, method of rigid bone fixation and similarity of materials. The new plates do not represent a major modification to system.
Intended use of the KLS-Martin Mandibular / Reconstructive System II is similar to the Synthes Universal 2.4mm Locking Plate System (K961421), Synthes 2.0 Locking Plate System (K974555), KLS-Martin Mandibular / Reconstruction System (K950045), KLS Mini Osteosynthesis System (K943347), OSTEOMED 2.0 Locking Plates and Screws (K030448), the function of this system being to affix Mandibular bony fragments.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2003
Ms. Jennifer Damato Director Regulatory Affairs Quality Assurance KLS Martin L.P. 11239-1 Street Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K032442
Trade/Device Name: KLS Martin Mandibular / Reconstruction System II Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: August 4, 2003 Received: August 8, 2003
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding 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 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.
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Page 2 - Ms. Damato
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Quls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for KLS Martin L.P. The logo consists of the letters "KLS" inside of a circle, which is inside of a shield shape. To the right of this is the word "martin" with a square around the letter "m", followed by the letters "L.P."
ksonville, FL 32250-0249 -800-625-1557 • Fax 904-641-7378
Indications for Use
510(k) Number (if known): K032442
Device Name: KLS Martin Mandibular / Reconstruction System II
Indications For Use:
The KLS Martin Mandibular / Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulvey for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Numbe
Prescription Use
X
Use
(Per 21 CFR 801-109)
OR
Over-The-Counter
(Optional Format 1-2-96)
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.