(70 days)
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Not Found
No
The device description and intended use clearly describe a mechanical fixation system for fractures, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is a compression fixation system used to treat fractures and osteotomies, which are therapeutic interventions.
No
The device is described as a "compression fixation system" for treating fractures, indicating it is a therapeutic device for stabilizing bones rather than diagnosing conditions.
No
The device description explicitly lists hardware components such as compression plates, lag screws, compression screws, bone screws, and angled blade plates.
No, 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 provide information about a person's health.
- Precimed Hip Screw System Function: The description clearly states that the Precimed Hip Screw System is a "compression fixation system used for the treatment of femoral neck and distal femoral fractures." It is a surgical implant used to stabilize bones.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information. Its purpose is purely therapeutic and structural.
Therefore, based on the provided information, the Precimed Hip Screw System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The Precimed Hip Screw System is a compression fixation system used for the treatment of femoral neck and distal femoral fractures. It consists of compression plates, lag screws, compression screws, bone screws and angled blade plates.
- Materials: The devices are manufactured from 316 LVM stainless steel or Titanium alloy 6Al-4V per ASTM and ISO standards.
- Function: The system functions to provide immediate stability and temporary fixation during the natural healing process following fractures of the femoral neck or distal femur.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femoral neck, distal femoral, hip
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
AMBI Hip Screw System ( S &N Richards ), HDS / DCS Dynamic Hip & Condylar Screw System ( Synthes ), Syntec-Taichung DHS / DCS Plate System ( Syntec-Taichung Medical Instrument Co. )
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
JAN 2 8 2003 K023851
Summary of Safety and Effectiveness
for
Precimed Hip Screw System
This safety and effectiveness summary for the Previded as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
- Submitter : Precimed, Inc. 50 Devyn Drive Chester Springs, PA 19425
Date Prepared: November 15, 2002
Contact Person : Barbara Lyons 50 Devyn Drive Chester Springs, PA 19425 Telephone: (610 ) 524-8300
- Tradename: Precimed Hip Screw System Compression Hip Screw and Supracondylar Plate System Common Name: Classification Name: Single/ multiple component metallic bone fixation appliances and accessories ( 888.3030 )
3. Predicate or legally marketed devices which are substantially equivalent:
- AMBI Hip Screw System ( S &N Richards ) .
- . HDS / DCS Dynamic Hip & Condylar Screw System ( Synthes )
- Syntec-Taichung DHS / DCS Plate System ( Syntec-Taichung Medical Instrument Co. ) .
4. Description of the device :
The Precimed Hip Screw System is a compression fixation system used for the treatment of femoral neck and distal femoral fractures. It consists of compression plates, lag screws, compression screws, bone screws and angled blade plates.
- Materials: The devices are manufactured from 316 LVM stainless steel or Titanium alloy 6Al-4V per ASTM and ISO standards.
- The system functions to provide immediate stability and temporary fixation during Function: the natural healing process following fractures of the femoral neck or distal femur.
5. Intended Use:
The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femoral fractures.
-
- Comparison of the technological characteristics of the device to predicate and legally marketed devices :
There are no significant differences between the Precimed Hip Screw System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, materials and intended use.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices :
1
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2003
Ms. Barbara Lyons Precimed, Inc. 50 Devyn Drive Chester Springs, Pennsylvania 19425
Re: K023851 Trade Name: Precimed Hip Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: November 15, 2002 Received: November 19, 2002
Dear Ms. Lyons:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
2
Page 2 - Ms. Barbara Lyons
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) 594-4659. 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,
Sincerely yours,
Mark A Milkerss
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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Page 1 of 1
510(k) Number (if known ) :
Device Name : Precimed Compression Hip Screw System
KOD 3851 Indications For Use :
The Precimed Hip Screw System is indicated for use in the treatment of dis-placed sub-capital fractures, subtrochanteric and intertrochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip, medial displacement osteotomies, supracondylar and distal femur fractures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED ) ---------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation ( ODE )
Prescription use > ( PER 21 CFR 801.109)
OR
Over-the-counter use
( optional format 1-2-96 )
Mark A. Milliken
17 - Off Restorative
K02385