(88 days)
Not Found
No
The document describes a physical medical device (interference screws) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for the reattachment of ligament, tendon, or soft tissue to bone, which constitutes a therapeutic intervention aimed at restoring function and healing.
No
Explanation: The device, Smith & Nephew PEEK Interference Screws, is described as an implantable screw used for reattaching ligaments, tendons, or soft tissue to bone. Its indicated uses are for various surgical repairs and reconstructions in different anatomical sites. This function is therapeutic/reparative, not diagnostic.
No
The device description clearly states it is a physical interference screw made of PEEK material, which is a hardware component.
Based on the provided information, the Smith & Nephew PEEK Interference Screws are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the screws are for the reattachment of ligament, tendon or soft tissue to bone during surgical procedures. This is a therapeutic and structural function within the body.
- Device Description: The description confirms they are interference screws for use in fixation of grafts to bone. This describes a physical implant used to hold tissues in place.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Smith & Nephew PEEK Interference Screws are surgical implants used to repair and stabilize tissues within the body.
N/A
Intended Use / Indications for Use
The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:
Shoulder: Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot/Ankle: Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/ tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.
Elbow/Hand/Wrist: Biceps Tendon Reattachment,Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair
Knee: Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair
Product codes
MBI, HWC
Device Description
The Smith & Nephew PEEK Interference Screws, consisting of non-absorbable PEEK material, are interference screws for use in fixation of ligament, tendon or soft tissue grafts to bone in shoulder, elbow, knee, foot/ankle and hand/wrist procedures. The screws are cannulated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Knee, Foot/Ankle, Hand/Wrist
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)
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew PEEK Interference Screws are substantially equivalent to the Smith & Nephew Bioraptor 2.3PK and the Arthrex Interference Screw
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 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
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810
978 749 1000 978 749 1599 Fax ww.smilh-nephew.com
- We are smith&nephew
JAN 3 0 2009
SECTION IV
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew PEEK Interference Screws
Date Prepared: 10/31/2008
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover, MA 01810
B. Company Contact
Kathy Reddig, RAC Regulatory Affairs Specialist II 978-749-1321 Phone 978-749-1443 Fax
C. Device Name
| Trade Name: | Smith & Nephew PEEK Interference Screws |
|---|---|
| Common Name: | Fastener, Fixation, Non-degradable, Soft tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
D. Predicate Devices
The Smith & Nephew PEEK Interference Screws are substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Bioraptor 2.3PK (K071586) and Arthrex Interference Screw (K062466)
1
K083226(2g2)
E. Description of Device
The Smith & Nephew PEEK Interference Screws, consisting of non-absorbable PEEK material, are interference screws for use in fixation of ligament, tendon or soft tissue grafts to bone in shoulder, elbow, knee, foot/ankle and hand/wrist procedures. The screws are cannulated.
Intended Use
The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:
Shoulder:
Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot/Ankle:
Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/ tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.
Elbow/Hand/Wrist:
Biceps Tendon Reattachment,Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair
Knee:
Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair
Comparison of Technological Characteristic F.
The Smith & Nephew PEEK Interference Screws are substantially equivalent in intended use, technological characteristics, and are as safe and as effective as their currently marketed predicate devices, the Smith & Nephew Bioraptor 2.3PK (K071586) and the Arthrex Interference Screw (K062466)
G. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew PEEK Interference Screws are substantially equivalent to the Smith & Nephew Bioraptor 2.3PK and the Arthrex Interference Screw
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc., Endoscopy Division % Ms. Kathy Reddig, RAC 150 Minuteman Road Andover, Massachusetts 01810
JAN 30 2009
Re: K083226
Trade/Device Name: Smith & Nephew PEEK Interference Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC Dated: October 31, 2008 Received: November 3, 2008
Dear Ms. Reddig:
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. Iisting 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Kathy Reddig, RAC
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 premarket notification" (21CFR 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 Millerson
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):
Device Name:
Smith & Nephew PEEK Interference Screws
The Smith & Nephew PEEK Interference Screws are indicated for the reattachment of ligament, tendon or soft tissue to bone for the following:
Shoulder:
Bankart Repair, Anterior Shoulder Instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstruction, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot/Ankle:
Hallux Valgus ,Lateral stabilization, Medial stabilization, Achilles Tendon repair/recon, Midfoot reconstruction, Metatarsal Ligament/ tendon repair, Bunionectomy, Flexor Hullucis Longus repair, Tendon Transfers.
Elbow/Hand/Wrist:
Biceps Tendon Reattachment,Ulnar or Radial Collateral Ligament Recon, Lateral Epicondylitis Repair, Scapholunate Ligament Recon, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Recon / Repair
Knee:
Medial or Lateral Collateral ligament, Posterior oblique ligament, Vastus medialis obliquous advancement, iliotibial band tenodesis, ACL Repairs, MCL Repairs, LCL Repairs, Patellar tendon repair, Posterior Oblique ligament repair
Prescription Use x
AND/OR
(Per 21 CFR 801 Subpart D)
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Page 18 of 95
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices