(72 days)
Not Found
No
The device description and intended use are purely mechanical/material-based, and there is no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as an interference screw for graft fixation during ACL/PCL reconstruction, which is a structural implantation device rather than a therapeutic device.
No.
The device is described as a screw used for fixation during ligament reconstruction surgery, not for diagnosing conditions.
No
The device description clearly states it is a physical screw made of polylactic acid and hydroxylapatite, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of bone-tendon-bone or soft tissue grafts during ACL/PCL reconstruction. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a screw made of materials designed to be implanted into bone. This is a surgical implant, not a device used to examine specimens in vitro (outside the living body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical tool used to physically secure tissue within the body.
N/A
Intended Use / Indications for Use
The Smith & Nephew PLLA/HA Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Product codes
HWC
Device Description
The Smith & Nephew PLLA/HA Screw is an tapcred interference screw for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery. The PLLA/HA Screw is a cannulated, sterile, single use bone screw, made of polylactic acid, a resorbable polymer, and hydroxylapatite, an inorganic ceramic.
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)
Results of product validation testing demonstrates substantial equivalence to the predicate devices; HAPLA Interference Screw (K002274) and the PLC Screw (K051310).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
APR 2 3 2008
As required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon
which the substantial equivalence is based.
PILLA/HA Screw
Date Prepared: February 8, 2008
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Deana Boushell Principal Regulatory Specialist T 508 337 4036 F 508 261 3620
C. Device Name
| Trade Name: | PLLA/HA Screw |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
D. Predicate Devices
The Smith & Nephew PLLA/HA Screw is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution:
E. Description of Device
The Smith & Nephew PLLA/HA Screw is an tapcred interference screw for fixation of bone-tendon-bone or soft tissue grafts during anterior or posterior cruciate ligament reconstruction surgery.
1
page of
F. Intended Üse
The Smith & Nephew PLLA/HA Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
G. Comparison of Technological Characteristics
The Smith & Nephew PLLA/HA Screw is essentially identical to the HAPLA Interference Screw and the PLC Screw described in K002274 and K051310 respectively. The PLLA/HA Screw is a cannulated, sterile, single use bone screw, made of polylactic acid, a resorbable polymer, and hydroxylapatite, an inorganic ceramic.
H. Summary Performance Data
Results of product validation testing demonstrates substantial equivalence to the predicate devices; HAPLA Interference Screw (K002274) and the PLC Screw (K051310).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2008
Smith & Nephew, Inc. Endoscopy Division c/o Ms. Deana Boushell Principal Regulatory Specialist 150 Minuteman Road Andover, MA 01810
K080358 Re:
Trade/Device Name: PLLA/HA Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 8, 2008 Received: February 11, 2008
Dear Ms. Boushell:
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 r ou may, areresters, while 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 r loase be action and a determination that your device complies with other requirements of the Act that I Dri has intace a and regulations administered by other Federal agencies. You must or any I 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 CI IC I art 007), accums (21 CFR Part 820); and if applicable, the electronic forul in also quany 25thons (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -- Ms. Deana Boushell
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (2 roy 27 et notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 510(k) Number (if known): ¥080] 58
Device Name: PLLA/HA Screw
Indications for Use:
The Smith & Nephew PLLA/HA Screw is indicated for fixation of bone-tendonbone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.
Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogle Axman
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K080358