(90 days)
Not Found
Not Found
No
The summary describes a mechanical implant system for fracture fixation and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended to treat fractures of the proximal femur, which is a therapeutic purpose.
No
The device is a surgical implant (nail) used to fix fractures in the femur. It is not used to diagnose medical conditions but rather to treat them.
No
The device description clearly states it consists of physical components like a cannulated intermedullary nail, helical blade, and end cap, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating bone fractures in the proximal femur. This is a surgical implant used directly on the patient's body.
- Device Description: The description details a surgical implant (nail, blade, end cap) designed to be inserted into bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is a surgical implant used inside the body for structural support and fracture fixation.
N/A
Intended Use / Indications for Use
Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long Trochanteric Fixation Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Product codes
HSB, HWC
Device Description
Synthes (USA) Trochanteric Fixation Nail (TFN) System consists of a cannulated intermedullary nail, a cannulated helical blade and cannulated nail end cap. The TFN Nail is anatomically contoured with a proximal diameter of 17 mm, tapering to a nominal diameter of 10, 11 or 12 mm. The tuporing locking hole accommodates angles ranging from t 125 - 135°. TFN nails arc to be available in short lengths (170 - 235 mm) and long lengths (300 - 460 mm), with the long length nails available in right or left versions. The Trochanteric Fixation Nail accepts commercially available Synthes 4.9 mm Locking Bolts and/or 5.0 mm Locking Screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur; trochanteric and diaphyseal regions
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Howmedica Gamma® Nail System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Koll 8:57
Summary of Safety and Effectiveness Information: 3.
Synthes (USA) Sponsor 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Bonnie Smith Synthes (USA) Trochanteric Fixation Nail System Device Name: 21 CFR 888.3030: "Single/multiple component metallic Device Classification: bone fixation appliances and accessories" and 888.3040: "Smooth or threaded metallic bone fixation fastener". Howmedica Gamma® Nail System, including modifications Predicate Device: for the Long Length and Short Length Gamma® Nails. Synthes (USA) Trochanteric Fixation Nail (TFN) System Description of Device: consists of a cannulated intermedullary nail, a cannulated helical blade and cannulated nail end cap. The TFN Nail is anatomically contoured with a proximal diameter of 17 mm, tapering to a nominal diameter of 10, 11 or 12 mm. The tuporing locking hole accommodates angles ranging from t 125 - 135°. TFN nails arc to be available in short lengths (170 - 235 mm) and long lengths (300 - 460 mm), with the long length nails available in right or left versions. The Trochanteric Fixation Nail accepts commercially available Synthes 4.9 mm Locking Bolts and/or 5.0 mm Locking Screws. Synthes Trochanteric Fixation Nail System is intended to Indications: treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long Trochanteric Fixation Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Material:
Titanium alloy
Premarket Notification 510(k) Synthes (USA) Trochanteric Fixation Nail System CONFIDENTIAL
000005
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white emblem. The emblem features a stylized eagle with its wings spread, facing right. The eagle is composed of three thick, curved lines. Encircling the eagle is text that reads 'HEALTH & HUMAN SERVICES - USA'. The text is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2001
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301
Re: K011857 Trade Name: Synthes (USA) Trochanteric Fixation Nail System Regulation Number: 21 CFR 888.3020 and 888.3040 Regulation Name: Intramedullary fixation rod Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HSB, HWC Dated: June 13, 2001 Received: June 14, 2001
Dear Ms. Smith:
This letter corrects our substantially equivalent letter of September 12, 2001, regarding the device name, regulation number and name, and product code.
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
2
Page 2 - Ms. Bonnie J. Smith
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and quality by sections (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) This letter will anow you to begin manoling your every alence of your device to a legally promates nealicate 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 additionally 21 - 11 - 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 597 1009. The Office of Compliance at (301) 594-4639. Also, Please note the your dones, prodo ochider and o by reference to premarket notification" (21CFR Part 807.97). Tegulation on the responsibilities under the Act may be obtained from the Other general information on your 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/dsmamain.html".
Sincerely yours,
Sincerely yours,
Mark N Millerson
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
3
Indications for Use 2.
Page_1_ of____________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name:
Indications for Use:
Synthes (USA) Trochanteric Fixation Nail System
Synthes Trochanteric Fixation Nail (TFN) System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, mending portrosies, and combinations thereof. The Long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
(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_ |
|---|---|---|
| --------------------------------------- | ---- | ----------------------- |
| Premarket Notification 510(k)
Synthes (USA) Trochanteric Fixation Nail System
| CONFIDENTIAL |
|---|
| -------------------------------------------------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of General, Restorative and Neurological Devices |
| 510(k) Number | K011857 | 000004 |
|---|---|---|
| --------------- | --------- | -------- |