(87 days)
Not Found
No
The description focuses on the mechanical design and intended use of a hip screw system, with no mention of AI or ML capabilities.
Yes
The device is indicated for treating fractures of the proximal femur and for proximal femoral osteotomies, which are therapeutic interventions.
No
The device description clearly states it is a "Hip Screw System" used to stabilize fractures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like plates, screws, and barrels, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating fractures and osteotomies of the proximal femur. This is a surgical intervention on the human body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a hip screw system, which is an implantable medical device used in orthopedic surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each paticular situation.
Product codes (comma separated list FDA assigned to the subject device)
87LXT
Device Description
The TK2 Hip Screw System will be a fixed-angle plate with the option to be rotationally locked. The system will offer two lag screws: one with external keys to rotationally "lock," and the other without keys. The design will allow the lag screw assembly to slide within the barrel to ensure continuous compaction of the fracture sight, transfer of the bone instead of the implant, and reduce the risk of acetabular penetration.
The plates will initially be offered in 2 through 14 hole lengths. The plate will be offered in all lengths in 130°, 135°, 140°, 145°, and 150°; and in a short barrel and standard barrel lengths. The lag screws will initially be offered in a keyed and keyless version in lengths from 50mm through 140mm. The lag screws will be offered in a super and standard thread form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur
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): 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.
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
K972639
510(k) SUMMARY
Image /page/0/Picture/1 description: The image shows the logo for DePuy ACE. The logo consists of a black circle followed by the text "DePuyACE" in a bold, sans-serif font. The letters are all capitalized, and the word "ACE" is slightly larger than "DePuy". There is a small TM symbol in the bottom right corner of the logo.
510(k) SUMMARY
| NAME OF FIRM: | OCT
- 9 1997
DePuy ACE Medical Company
2260 East El Segundo Boulevard
El Segundo, CA 90245 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT PERSON: | Kathleen Dragovich
Regulatory Affairs Specialist
DePuy ACE Medical Company |
| TRADE NAME: | DePuy ACE TK2 Hip Screw System |
| COMMON NAME: | Compression Hip Screw |
| CLASSIFICATION: | 888.3030 Single/multiple component metallic bone
fixation appliances and accessories |
| DEVICE CODE: | 87LXT |
| SUBSTANTIALLY
EQUIVALENT DEVICE: | Synthes Dynamic Hip Screw (DHS) System and
DePuy ACE Select Lock Hip Screw System |
INTENDED USE:
The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each paticular situation.
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The TK2 Hip Screw System will be a fixed-angle plate with the option to be rotationally locked. The system will offer two lag screws: one with external keys to rotationally "lock," and the other without keys. The design will allow the lag screw assembly to slide within the barrel to ensure continuous compaction of the fracture sight, transfer of the bone instead of the implant, and reduce the risk of acetabular penetration.
The plates will initially be offered in 2 through 14 hole lengths. The plate will be offered in all lengths in 130°, 135°, 140°, 145°, and 150°; and in a short barrel and standard barrel lengths. The lag screws will initially be offered in a keyed and keyless version in lengths from 50mm through 140mm. The lag screws will be offered in a super and standard thread form.
The DePuy ACE TK2 Hip Screw System is similar in design to the Synthes Dynamic Hip System (510k approval K791619) and the DePuy ACE Select Lock Hip Screw System (regulatory assessment approval based on K861178 released 4/15/86), which are indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies
Based on the above information, DePuy ACE Medical Company firmly believes that the new DePuy ACE TK2 Hip Screw System is substantially equivalent to the Synthes Dynamic Hip Screw System and the DePuy ACE Select Lock Hip Screw System.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen A. Draqovich Requlatory Affairs Specialist DePuy, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
OCT - 9 1997
Re: K972629 Trade Name: DePuy Ace TK2 Hip Screw System Requlatory Class: II Product Code: KTT Dated: July 11, 1997 Received: July 14, 1997
Dear Ms. Dragovich:
We have reviewed your Section 510(k) 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). 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 reqistration, 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 (Premarket Approval), 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 895. ಕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Kathleen A. Dragovich
This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known)
DePuy ACE TK2 Hip Screw System Device Name:
Indications For Use:
ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each patient's particular situation.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter
tacoello
(Division Sign-Off) (Division of General Restorative Device 510(k) Number