(90 days)
Not Found
No
The device description and intended use describe a mechanical screw for surgical fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an interference screw used for internal fixation of grafts in ligament reconstruction, not a device that provides therapy or treatment.
No
The device is a surgical implant (interference screw) used for fixation of grafts in ligament reconstruction, not for diagnosis of a condition.
No
The device description clearly states it is a system of cannulated fully threaded cancellous bone screws made from titanium alloy and Poly-L-lactic acid, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The DePuy Interference Screw Systems are described as surgical implants (screws) used to fix grafts during ligament reconstruction surgery. They are physically implanted into the body to provide mechanical support.
- Lack of Biological Sample Testing: The provided information does not mention any testing of biological samples from the patient. The device's function is purely mechanical and structural within the body.
Therefore, based on the provided information, the DePuy Interference Screw Systems are medical devices used in surgery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DePuy Interference Screw Systems are intended to provide interference fixation of bone-patellar tendon-bone grafts in ACL and PCL reconstruction and of soft tissue grafts in ACL reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
87 HWC and MAI
Device Description
The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Mechanical testing has shown that the mean pull-out loads of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those published for the previously cleared Linvatec BioScrew indicated for interference fixation in PCL reconstruction.
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.
K955733, K981670, K961234, K960652, K960940
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
§ 888.3040 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.
0
OCT 28 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|----------------------|----------------------------------------------------------------------------------------------|
| FIRM CONTACT: | Sally Foust
Senior Regulatory Submissions Associate |
| TRADE NAME: | DePuy Profile™ Round Head Interference Screw
DePuy Phantom™ Resorbable Interference Screw |
| COMMON NAME: | Bone Screw |
| CLASSIFICATION: | 888.3040 Smooth or threaded metallic bone fixation fastener |
| DEVICE PRODUCT CODE: | 87 HWC and MAI |
SUBSTANTIALLY EQUIVALENT DEVICES:
•DePuy Phantom Absorbable Interference Screw (K955733, K981670) •DePuy Profile Round Head Interference Screw (K961234, K981670) ·Linvatec BioScrew Absorbable Interference Screw (K960652, K960940)
DEVICE DESCRIPTION AND INTENDED USE: The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws available in three diameters (7, 8, and 9mm) in three lengths (20, 25,and 30mm), and manufactured from titanium alloy (DePuy Profile Round Head Interference Screw) and from Poly-L-lactic acid (DePuy Phantom Absorbable Interference Screw).
The DePuy Interference Screw Systems are intended to provide interference fixation of bone-patellar tendon-bone grafts in ACL and PCL reconstruction and of soft tissue grafts in ACL reconstruction.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Profile Round Head and the Phantom Absorbable Interference Screws are identical in design and materials to the DePuy Profile Round Head and Phantom Absorbable Interference screws which have been previously been cleared by FDA for interference fixation of bone-patellar tendon-bone grafts in ACL reconstruction and of soft tissue grafts in ACL reconstruction. The only difference between this submission and the previously cleared submission is the additional indication for interference fixation of bone-patellar tendon-bone grafts in PCL reconstruction.
Mechanical testing has shown that the mean pull-out loads of the Profile Round Head Interference Screws and the Phantom Absorbable Interference Screws are comparable to those published for the previously cleared Linvatec BioScrew indicated for interference fixation in PCL reconstruction.
000004
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three wavy lines representing the body. The figure is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 28 1998
Ms. Sally Foust Senior Regulatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K982662 Re: DePuy Profile Round Head Interference Screw Trade Name: and DePuy Phantom Interference Screw II Regulatory Class: Product Codes: HWC, MBI, and MAI Dated: July 29, 1998 Received: July 30, 1998
Dear Ms. Foust:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 regulation may result in regulatory In addition, FDA may publish further announcements action. 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. Sally Foust
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 leqally 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 diaqnostic 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known) (982622
Device Name DePuy Interference Screw Systems - Additional Indication/Intended Use to Provide Interference Fixation of Bone-Patellar Tendon-Bone Grafts in Posterior Cruciate Ligament (PCL) Reconstruction
Indications for Use:
The DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction and of soft tissue grafts in ACL reconstruction.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation
boceto
(Division Division of General Restora 510(k) Number
Prescription Use_ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use