(23 days)
Not Found
No
The device description and intended use describe a mechanical bone distractor with no mention of AI or ML components or functions.
Yes.
The device is used for finger reconstruction after amputation or malformation, which is a therapeutic purpose to restore function or form.
No
The device is described as a "subcutaneous bone distractor" used in finger reconstruction, indicating a therapeutic or reconstructive purpose rather than diagnosing a condition.
No
The device description clearly states it is a "subcutaneous bone distractor" with "two telescoping jackscrew components activated by, fixed to the bone with plates and secured with titanium bone screws," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The KLS Martin Hand Distractor is a surgical device designed to be implanted and used directly on bone tissue within the body for reconstruction. It does not analyze specimens taken from the body.
- Intended Use: The intended use is for surgical reconstruction of bones, not for analyzing biological samples.
Therefore, based on the provided information, the KLS Martin Hand Distractor is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The KLS Martin Hand Distractor is designed to be used in finger reconstruction of the thumb or the metacarpal bones 1 - IV after amputation or malformation.
Product codes
JEC
Device Description
The KLS Martin Hand Distractor is a subcutaneous bone distractor. It features two components activated by telescoping jackscrew, fixed to the bone with plates and secured with titanium bone screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger reconstruction of the thumb or the metacarpal bones 1 - IV
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K973275, K983515, K971755, K965029
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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AUG 2 5 2004
042066
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ાંડ
a
a
510(K) SUMMARY
KLS-Martin, L.P. Submitter: 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246 904-641-7746 Phone: Fax: 904-641-7378 Jennifer Damato Contact Person: Director RA/QA 27 July 2004 Date of Summary: KLS-Martin Hand Distractor Device Name: KLS-Martin Hand Distractor Trade Name: Internal Distractor Common Name: Classification Smooth or threaded metallic bone fixation Name and Number: fastener (CFR 888.3040) Class II Requlatory Class: KLS-Martin Intraoral Distractor (K973275) Predicate Devices: KLS-Martin Intra-Oral Mandibular Distractor (K983515) Hoffmann II Compact External Fixation System (K971755) Acumed Stableloc II External Fixation System (K965029) The KLS Martin Hand Distractor is designed to Intended Use: be used in finger reconstruction of the thumb or the metacarpal bones 1 - IV after amputation or malformation. Device Distractor Martin Hand KLS The Description: subcutaneous bone distractor. It features two activated by components telescoping jackscrew, fixed to the bone with plates and secured with titanium bone screws.
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042066
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Technological Characteristics:
Similarities to Predicate
Distractor is KLS-Martin Hand a The distractor similar in subcutaneous bone technology and design to the KLS-Martin Intra-Oral Mandibular Distractor (K983515) and KLS-Martin Intra-Oral Distractor (K973275).
The KLS-Martin Hand Distractor is similar in intended use as the Hoffmann II Compact External Fixation System (K971755) Acumed System Stableloc External Fixation (K965029)
Differences to Predicate
Intra-Oral Mandibular KLS-Martin The Distractor (K983515) and KLS-Martin Intra-Oral Distractor (K973275) are designed for the mandible and the KLS-Martin Hand Distractor is designed for distraction of the thumb and metacarpal bones.
The Hoffmann II Compact External Fixation (K971755) Acumed Stableloc II System Fixation System (K965029) are External external devices and the KLS-Martin Hand Distractor is a subcutaneous bone distractor.
Substantial Equivalence:
The KLS-Martin Hand Distractor is substantially equivalent in design and manufacturing to the KLS-Martin Intra-Oral Mandibular Distractor (K983515) and KLS-Martin Intra-Oral Distractor (K973275) and substantially equivalent in intended use as the Hoffmann II Compact External Fixation System (K971755) Acumed Stableloc II External Fixation System (K965029).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2004
Ms. Jennifer Damato Director, Regulatory Affairs KLS-Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K042066
Trade/Device Name: KLS Martin Hand Distractor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: JEC Dated: July 27, 2004 Received: August 2, 2004
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.
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.
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Page 2 - Ms. Jennifer Damato
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) 594-4692. 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,
O. Mark A. Mellauso
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: KLS Martin Hand Distractor
Indications For Use:
The KLS Martin Hand Distractor is designed to be used in finger reconstruction of the thumb or the metacarpal bones I - IV after amputation or malformation.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of the Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number_ K042066
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