(156 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is described as a "soft-tissue fixation device" used for "soft-tissue to bone fixation" in various joints, indicating it is used to repair or stabilize injured tissues, which is a therapeutic function.
No
Explanation: The device is described as a soft-tissue fixation device used for surgical repairs, not for identifying, diagnosing, or monitoring diseases or conditions.
No
The device description clearly states it is a physical implant (soft-tissue fixation device) composed of a sheath structure and sutures, provided preloaded on a disposable inserter. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Stryker All Suture Anchors Function: The description clearly states that these anchors are "soft-tissue fixation devices" used for "soft-tissue to bone fixation" during surgical procedures. They are implanted into the body to hold tissues in place.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Stryker All Suture Anchors are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Stryker All Suture Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. See indications below.
Shoulder: Rotator Cuff repair, Bankart repair, SLAP lesion repair, Biceps tendonesis, Acromioclavicular separation repair, Deltoid Repair, Capsular shift or capsulolabral repair
Elbow: Biceps Tendon re-attachment, ulnar or radial collateral ligament reconstruction
Hand/Wrist: Scaphulolunate ligament reconstruction, carpal ligament reconstruction, repair/reconstruction of collateral ligaments, repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joint for all digits, digital tendon repair
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, metatarsal ligament repair, hallux valgus reconstruction, digital tendon transfers, mid-foot reconstruction
Knee: Medial Collateral Ligament repair, Lateral Collateral Ligament repair, Patellar tendon repair, Posterior oblique ligament repair, iliotibial band tendonesis.
Hip: Capsular repair, acetabular labral repair
The Stryker All Suture Anchors are supplied sterile and intended for single use only.
Product codes
MBI
Device Description
The Stryker All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hip, hand, wrist, elbow and shoulder
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)
Non-clinical bench testing was performed to verify both the insertion strength and fixation strength of the Stryker All Suture Anchors. Through ultimate tensile strength testing and an FEA analysis, the efficacy of the Stryker All Suture Anchors was compared to the predicate devices identified within this premarket notification. The results of these evaluations indicate that the Stryker All Suture Anchors provide statistically equivalent insertion and fixation strength to the predicate devices, and will be functional within the intended use.
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
K120509 (112)
JUL 26 2012
510(k) Summary of Safety and Effectiveness
| Proprietary Name: | Stryker All Suture Anchors |
|---|---|
| Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation fastener |
| 21 CFR §888.3040 | |
| Proposed Regulatory Class: | Class II |
| Product Codes: | MBI: Fastener, Fixation, Nondegradable, Soft Tissue |
| For Information Contact: | Kelly Kucharczyk |
| Regulatory Affairs Associate | |
| Howmedica Osteonics Corp. | |
| 3201 E. 3rd Ave | |
| Denver, CO 80210 | |
| Phone: (303) 336-7285; Fax (303) 370-5775 | |
| Email: kelly.kucharczyk@stryker.com | |
| Legally Marketed Devices to Which | |
| Substantial Equivalence Is Claimed: | K070882 - Stryker PEEK TwinLoop Tac |
| K110145 - Biomet JuggerKnot | |
| Date Prepared: | July 24, 2012 |
Purpose
Stryker Endoscopy is introducing a family of soft tissue anchors for use in orthopedic applications.
Description
The Stryker All Suture Anchors are soft-tissue fixation devices with a push-in design, provided preloaded on a disposable inserter. They are composed of a sheath structure that contains one or more working sutures. The sheath bunches as the anchor is deployed to fixate in bone.
Intended Use
The Stryker All Suture Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. See indications below.
1
Indications
Shoulder: Rotator Cuff repair, Bankart repair, SLAP lesion repair, Biceps tendonesis, Acromioclavicular separation repair, Deltoid Repair, Capsular shift or capsulolabral repair
Elbow: Biceps Tendon re-attachment, ulnar or radial collateral ligament reconstruction
Hand/Wrist: Scaphulolunate ligament reconstruction, carpal ligament reconstruction, repair/reconstruction of collateral ligaments, repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joint for all digits, digital tendon repair
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, metatarsal ligament repair, hallux valgus reconstruction, digital tendon transfers, mid-foot reconstruction
Knee: Medial Collateral Ligament repair, Lateral Collateral Ligament repair, Patellar tendon repair, Posterior oblique ligament repair, iliotibial band tendonesis.
Hip: Capsular repair, acetabular labral repair
The Stryker All Suture Anchors are supplied sterile and intended for single use only.
Summary of Technologies
The proposed device is substantially equivalent to other commercially available soft-tissue anchors in regard to intended use, design, materials of construct, performance attributes, and operational principles as a soft tissue anchor. The following devices are examples of predicate systems: Stryker PEEK TwinLoop Tac (marketed by the name - PEEK TwinLoop Anchor) and Biomet JuggerKnot Soft Anchor.
Non-Clinical Testing
Non-clinical bench testing was performed to verify both the insertion strength and fixation strength of the Stryker All Suture Anchors. Through ultimate tensile strength testing and an FEA analysis, the efficacy of the Stryker All Suture Anchors was compared to the predicate devices identified within this premarket notification. The results of these evaluations indicate that the Stryker All Suture Anchors provide statistically equivalent insertion and fixation strength to the predicate devices, and will be functional within the intended use.
Clinical Testing
Clinical testing was not required for this submission.
Conclusion
The Stryker All Anchors are substantially equivalent to the predicate devices identified in this premarket notification.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, rendered in a simple, bold design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 26 2012
STRYKER % Ms. Kelly Kucharczyk Regulatory Affairs Associate 3201 East 3rd Avenue Denver. Colorado 80206
Re: K120509
Trade/Device Name: Stryker All Suture Anchor(s) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: July 13, 2012 Received: July 16, 2012
Dear Ms. Kucharczyk:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 – Ms. Kelly Kucharczyk
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Sincerely yours,
Enclosure
4
K120509 (11)
7
Indications for Use
510(k) Number (if known):
Device Name: Stryker All Suture Anchor(s)
Elbow: Biceps Tendon re-attachment, ulnar or radial collateral ligament reconstruction
Shoulder: Rotator Cuff repair, Bankart repair, SLAP lesion repair, Biceps tendonesis, Acromio clavicular separation repair, Deltoid Repair, Capsular shift or capsulolabral repair
Hand/Wrist: Scaphulolunate ligament reconstruction, carpal ligament reconstruction, repair/reconstruction of collateral ligaments, repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joint for all digits, digital tendon repair
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, metatarsal ligament repair, hallux valgus reconstruction, digital tendon transfers, mid-foot reconstruction
Knee: Medial Collateral Ligament repair, Lateral Collateral Ligament repair, Patellar tendon repair, Posterior oblique ligament repair, iliotibial band tendonesis:
Hip: Capsular repair, acetabular labral repair
The Stryker All Suture Anchors are intended for single use only.
Adint
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K12.0509
Over-The-Counter Use Prescription Use. X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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