(90 days)
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a medical screw used to fix a bone block in ligament reconstruction, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is an absorbable set screw intended for fixation of bone blocks in ACL reconstruction, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease, condition, or injury.
No
The device description clearly states it is a physical screw made of poly-L-lactic acid (PLLA), which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The DePuy DuPont Absorbable Set Screw is a physical implantable device used to fix bone tissue within the body during surgery.
- Intended Use: Its purpose is to provide mechanical fixation of a bone block during ACL reconstruction surgery, not to analyze biological samples.
The information provided clearly describes a surgical implant, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The DePuy DuPont Absorbable Set Screw is intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament (ACL) reconstruction.
Product codes
HWC, HWQ
Device Description
The DePuy DuPont Absorbable Set Screw is a fully threaded, cannulated, headless cancellous bone screw with a blunt tip. It is manufactured from poly-L-lactic acid (PLLA) and is available in a 9.0mm diameter in seven lengths (20, 25, 30, 35, 40, 45, and 50mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, bone-patellar-tendon-bone graft, anterior cruciate ligament
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)
K972494, Hyloc™ Interference Screw (DePuy DuPont), DePuy Set Screw M. Kurosaka Interference Screw (DePuy), DePuy Advantage Fixation Screw System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Clinical Affairs Associate (219) 372-7455 FAX (219) 267-7098 e-mail: Sally Foust(@ccgate.depuy.com
TRADE NAME: COMMON NAME: CLASSIFICATION: DEVICE PRODUCT CODE:
DePuy DuPont Absorbable Set Screw Bone/Tendon/Bone Screw 888.3040 Smooth or threaded bone fixation fastener 87 HWQ
SUBSTANTIALLY EQUIVALENT DEVICES: Hyloc™ Interference Screw (DePuy DuPont) DePuy Set Screw M. Kurosaka Interference Screw (DePuy) DePuy Advantage Fixation Screw System
DEVICE DESCRIPTION AND INTENDED USE: The DePuy DuPont Absorbable Set Screw is a fully threaded, cannulated, headless cancellous bone screw with a blunt tip. It is manufactured from poly-L-lactic acid (PLLA) and is available in a 9.0mm diameter in seven lengths (20, 25, 30, 35, 40, 45, and 50mm).
The DePuy DuPont Absorbable Set Screw is intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament (ACL) reconstruction. The screw is inserted by a square headed drive which is broached into the minor diameter of the screw body. The screw is used to compress the bone block against the wall of the bone tunnel and secure the ACL graft. The screw is gradually resorbed by the body.
BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy DuPont Absorbable Set Screw, Hyloc Interference Screw, DePuy Set Screw, M. Kurosaka Interference Screw, and the DePuy Advantage Fixation Screw System are all intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft fixation in anterior cruciate ligament (ACL) reconstruction, and employ the same principles of graft fixation. All of the substantially equivalent devices are fully threaded, cannulated, headless designs available in a diameter of 9mm. The DePuy DuPont Absorbable Set Screw and the Hyloc Interference Screw are both manufactured from poly-Llactic acid (PLLA) with the same specifications and obtained from the same supplier, and are implanted with a square driver, while the DePuy Set Screw, M. Kurosaka Interference Screw, and the DePuy Advantage Fixation Screw System are manufactured from titanium and are implanted with a hex driver. The DePuy DuPont Absorbable Set Screw, the Hyloc Interference Screw, and the DePuy Set Screw all have a blunt tip, while the M. Kurosaka Interference Screw has a pointed tip and the DePuy Advantage Fixation Screw System has a tapered tip. The DePuy DuPont Absorbable Set Screw, the Advantage Interference Screw and the DePuy Set Screw have the same thread form and pitch. The DePuv DuPont Absorbable Set Screw and the DePuy Set Screw are available in exactly the same lengths (20, 25, 30, 35, 40, 45, and 50mm).
000013
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 1997
:
Ms. Sally Foust Clinical Affairs Associate DePuy, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988
Re: K972494 DePuy DuPont Absorbable Set Screw Regulatory Class: II Product Code: HWC Dated: July 2, 1997 Received: July 3, 1997
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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This device, if intended for use in pedicular screw the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and
2
Page 2 - Ms. Sally Foust
You may not label or in any way promote this device for 2 . pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਕੈ 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 Requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
3
Page 3 - Ms. Sally Foust
If you desire specific advice for your device on our labeling II you debire bpos. Bart 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
the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be Information of Je Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its coll free namber (o://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
4
510(k) Number (if known)长ኖሯ249년
Device Name DePuy DuPont Absorbable Set Screw
Indications for Use:
The DePuy DuPont Absorbable Set Screw is intended to provide early fixation of the bone block in bone-patellar-tendon-bone graft in anterior cruciate ligament reconstruction.
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use X | OR Over-The-Counter Use |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | Rr 72494 |
|---|---|
| --------------- | ---------- |
000002