(57 days)
Not Found
No
The device description and intended use are for a physical suture anchor made of PEEK, sutures, and an inserter. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML.
Yes.
The device is used to secure soft tissue to bone during reconstructive surgery, which is a therapeutic intervention.
No
The device is a surgical anchor used to secure soft tissue to bone during reconstructive surgery. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical suture anchor made of PEEK and sutures, pre-assembled on a disposable inserter. It is a hardware device used in surgical procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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).
- Stryker PEEK Zip Suture Anchor Function: The description clearly states that this device is a "soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery." This is a surgical implant used within the body (in vivo) to repair anatomical structures.
The intended use and device description focus on surgical procedures and the physical function of the anchor in securing tissue to bone, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Stryker PEEK Zip Suture Anchor is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
- Rotator Cuff Repair
- Bankart Repair ■
- SLAP Lesion Repair
- Acromio-Clavicular Separation Repair
- 제 Capsular Shift/Capsulolabral Reconstruction
- Biceps Tenodesis
- Deltoid Repair.
Knee:
- Extra Capsular Repairs
- Medial Collateral Ligament ಂ
- Lateral Collateral Ligament o
- Posterior Oblique Ligament ు
- ﻻ Illiotibial Band Tenodesis
- Patellar Tendon Repair. 피
Elbow, Wrist, Hand:
- Scapholunate Ligament Reconstruction
- Ulnar Collateral Ligament Reconstruction
- Radial Collateral Ligament Reconstruction
- . Biceps Tendon Reattachment.
Foot and Ankle:
- Medial Instability Repair/Reconstruction
- Lateral Instability Repair/Reconstruction
- Achilles Tendon Repair/Reconstruction
- Midfoot Reconstruction
- Hallux Valgus Reconstruction.
Pelvis:
- Bladder Neck Suspension Procedures.
The Stryker PEEK Zip Suture Anchor is intended for single-use only.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Stryker PEEK Zip Suture Anchor is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The Stryker PEEK Zip Suture Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc. The screw-in anchor is pre-threaded with non-absorbable braided sutures and pre-assembled on a The suture will be offered in both non-absorbable USP braided polyester disposable inserter. suture (#K953531) and non-absorbable USP braided polyethylene suture (#K033654 and #K040472.). The Stryker PEEK Zip Suture Anchor will be validated to a SAL of 10° using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7:1995.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Elbow, Wrist, Hand, Foot, Ankle, Pelvis
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
§ 888.3040 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
MAY 16 2007
Image /page/0/Picture/3 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The letters are closely spaced, giving the word a compact appearance. The overall impression is a clean and modern logo.
Endoscopy
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Date: March 19, 2007
Contact Person:
Erica A. Walters, RAC Sr. Regulatory Representative 408-754-2078(phone) 408-754-2521 (fax) erica.walters@stryker.com
Device Name:
| Proprietary Name: | Stryker PEEK Zip Suture Anchor |
|---|---|
| Common and Usual Name: | PEEK Suture Anchor |
| Classification Name: | Screw, Fastener, Fixation, Nonabsorbable, Bone, Soft |
| Tissue (Class II, 21 CFR 888.3040, Product Code MBI, | |
| Orthopedics Review Panel) |
Predicate Devices:
Stryker 5.0mm BioZip Suture Anchor: # K023192, K041305 Arthrex 5.0mm PEEK Corkscrew FT: #K061665
Device Description and Intended Use:
The Stryker PEEK Zip Suture Anchor is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
- Rotator Cuff Repair
- Bankart Repair ■
- SLAP Lesion Repair
- Acromio-Clavicular Separation Repair
- 제 Capsular Shift/Capsulolabral Reconstruction
- Biceps Tenodesis
- Deltoid Repair.
Knee:
- Extra Capsular Repairs
- Medial Collateral Ligament ಂ
- Lateral Collateral Ligament o
- Posterior Oblique Ligament ు
- ﻻ Illiotibial Band Tenodesis
- Patellar Tendon Repair. 피
Elbow, Wrist, Hand:
- Scapholunate Ligament Reconstruction
- Ulnar Collateral Ligament Reconstruction
- Radial Collateral Ligament Reconstruction
- . Biceps Tendon Reattachment.
Foot and Ankle:
- Medial Instability Repair/Reconstruction
- Lateral Instability Repair/Reconstruction
- Achilles Tendon Repair/Reconstruction
- Midfoot Reconstruction
- Hallux Valgus Reconstruction.
Pelvis:
- Bladder Neck Suspension Procedures.
1
The Stryker PEEK Zip Suture Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc. The screw-in anchor is pre-threaded with non-absorbable braided sutures and pre-assembled on a The suture will be offered in both non-absorbable USP braided polyester disposable inserter. suture (#K953531) and non-absorbable USP braided polyethylene suture (#K033654 and #K040472.). The Stryker PEEK Zip Suture Anchor will be validated to a SAL of 10° using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7:1995.
Prior to introducing the Stryker PEEK Zip Suture Anchor to market, the device will conform to the following voluntary safety and performance standards: ISO 10993-1, Blue Book Memorandum G95-1, EN 550, EN 556-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971.
The material differences between the Stryker PEEK Zip Suture Anchor and Stryker BioZip Suture Anchor (K023192, K041305) do not affect the safety and efficacy of the product; therefore, the Stryker PEEK Zip Suture Anchor is considered substantially equivalent in performance, intended use, safety, and efficacy to the Stryker BioZip Suture Anchor.
The Stryker PEEK Zip Suture Anchor is considered substantially equivalent in material composition, intended use, safety and efficacy to the Arthrex PEEK Corkscrew FT (K061665).
By: Chutine Kysar
Date: 19 March 2007
Christine Krueger Design Engineer Stryker Endoscopy
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-like symbol with three curved strokes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Endoscopy % Erica A. Walters, RAC Sr. Regulatory Representative 5900 Optical Court San Jose, California 95138
MAY 16 2007
Re: K070758
Trade/Device Name: Stryker PEEK Zip Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 19, 2007 Received: April 3, 2007
Dear Ms. Walters:
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, 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 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
3
Page 2 - Erica A. Walters, RAC
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Karlaue Buehup
fell
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
Device Name: Stryker PEEK Zip Suture Anchor
K070758 510(k) Number if known:
The Stryker PEEK Zip Suture Anchor is a soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as:
Shoulder:
- Rotator Cuff Repair «
- Bankart Repair .
- . SLAP Lesion Repair
- Acromio-Clavicular Separation Repair .
- . Capsular Shift/Capsulolabral Reconstruction
- 프 Biceps Tenodesis
- I Deltoid Repair.
Knee:
- Extra Capsular Repairs .
- Medial Collateral Ligament o
- Lateral Collateral Ligament 0
- Posterior Oblique Ligament 0
- . Illiotibial Band Tenodesis
- I Patellar Tendon Repair.
Elbow. Wrist. Hand:
- Scapholunate Ligament Reconstruction .
- Ulnar Collateral Ligament Reconstruction
- · Radial Collateral Ligament Reconstruction
- Biceps Tendon Reattachment. .
Foot and Ankle:
- Medial Instability Repair/Reconstruction I
- · Lateral Instability Repair/Reconstruction
- · Achilles Tendon Repair/Reconstruction
- · Midfoot Reconstruction
- · Hallux Valgus Reconstruction.
Pelvis:
- Bladder Neck Suspension Procedures. .
The Stryker PEEK Zip Suture Anchor is intended for single-use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Barbara Buchup
Division of General. Restorative. and Neurological Devices
510(k) Number K0