(62 days)
Not Found
Not Found
No
The device description details a mechanical external fixator system with no mention of software, algorithms, or any components that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as providing "treatment" for various medical conditions, including fractures, nonunion, infections, tumor resections, and deformity corrections, which aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose as a "unilateral (uni-bar) external fixation frame" used for various bone treatments like fractures, unions, and deformity corrections, physically supporting or manipulating bones. It does not mention any function for identifying, evaluating, or predicting medical conditions or diseases.
No
The device description clearly outlines physical components made of materials like PEEK and stainless steel, which are hardware. The intended use also describes a physical external fixator system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Normed Mini External Fixator System is a surgical device used to stabilize and treat fractures and deformities in the small bones of the fingers and toes. It is applied externally to the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes related to detecting or monitoring diseases.
Therefore, the Normed Mini External Fixator System falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of finger and toe. The system provides treatment for small bone fractures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, burn maintenance, and bone grafting defects and fusion of a joint.
Product codes
87 HRS
Device Description
Normed Mini External Fixator System is a unilateral (uni-bar) external fixation frame consists of a series of clamps, rods and half pins. The frame is consists of Adjustable Polyetheretherketon (PEEK) Swivel Clamps, PEEK Simple Swivel Clamps, Stainless Steel Distraction/Compression Rods, PEEK Carbon Fiber Smooth Connecting Rods and Stainless Steel Half Pins. The 4mm rods are designed to provide a connecting element for the clamps and are available in 25,40,50 and 80 mm length.
The clamps are manufactured from Polyetheretherketon (PEEK) in one size. The adjustable swivel clamp will be used with stainless steel distraction/compression rods for dynamically applying distraction or compression to the small bones of finger and toe. The simple swivel clamp will be used with Polyetheretherketon PEEK carbon fiber stabilizer rods for static fixator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of finger and toe
Indicated Patient Age Range
The system can be used in both adult and pediatric patients.
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)
Not Found
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.
Not Found
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.
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SEP 1 0 2002
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510 (k) Summary
Device Name: Normed Mini External Fixator System
Device Identification: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Class II
Product Code: 87 HRS (21 CFR - 888.3030)
Normed Mini External Fixator System is a unilateral (uni-bar) external fixation frame consists of a series of clamps, rods and half pins. The frame is consists of Adjustable Polyetheretherketon (PEEK) Swivel Clamps, PEEK Simple Swivel Clamps, Stainless Steel Distraction/Compression Rods, PEEK Carbon Fiber Smooth Connecting Rods and Stainless Steel Half Pins. The 4mm rods are designed to provide a connecting element for the clamps and are available in 25,40,50 and 80 mm length.
The clamps are manufactured from Polyetheretherketon (PEEK) in one size. The adjustable swivel clamp will be used with stainless steel distraction/compression rods for dynamically applying distraction or compression to the small bones of finger and toe. The simple swivel clamp will be used with Polyetheretherketon PEEK carbon fiber stabilizer rods for static fixator.
Official Contact Person:
Albert Enavati President Osteomedics Inc. 809 Carter Lane Paramus, NJ 07652 Tel: (201) 444-7306 Fax: (201) 444-7395 E-mail: osteomedics(@aol.com
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 0 2002
Mr. Albert Enayati President Osteomedics, Inc. 809 Carter Lane Paramus, New Jersey 07652
Re: K022230
Trade/Device Name: Normed Mini External Fixator System Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulation Class: II Product Code: HRS Dated: June 23, 2002 Received: July 10, 2002
Dear Mr. Enayati:
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 - Mr. Albert Enayati
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
. Stypka Plurka
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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K002250
page 1 of 1
Indications for use
510 (k) Number ( if known):
Device Name: Normed Mini External Fixator System
Indications for use:
Normed Mini External Fixator System can be used as a static fixator or dynamically applying distraction or compression to the small bones of finger and toe. The system provides treatment for small bone fractures, including severe open finger and toe fractures, highly comminuted close fractures, monunion and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, figure and toe deformity corrections, burn maintenance, and bone grafting defects and fusion of a joint. The system can be used in both adult and pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Prescription use X
(Pcr 21 CFR 801.109)
OR OVER-THE-COUNTER USE
Styp Quorles
(Division Sign-Off) Division of General, Restorative and Neurological Devices
(Optional Format 1-2-96)
510(k) Number K072230
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