(169 days)
Not Found
No
The device description and intended use are for a physical surgical anchor and its insertion system, with no mention of software, data processing, or AI/ML capabilities.
No
The device is an anchor used to secure soft tissue to bone, which is a surgical fixation device and not typically classified as a therapeutic device.
No
Explanation: The Stryker XCEL Anchor System is described as a device intended for securing soft tissue to bone in various surgical procedures, primarily focusing on repair and reconstruction. Its components (PLLA anchor, sutures, inserter) and listed uses (e.g., Bankart repair, rotator cuff repair, Achilles tendon repair) are consistent with a therapeutic or surgical implant, not a diagnostic tool that identifies or characterizes a disease or condition.
No
The device description clearly states it is a physical anchor system made of PLLA and suture, pre-assembled on a disposable inserter, and used with instrumentation. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "securing soft tissue to bone in such procedures as..." followed by a list of surgical procedures. This describes a surgical implant used directly on a patient's body during a procedure.
- Device Description: The description details a "Poly L-lactic acid (PLLA) anchor pre-threaded with nonabsorbable, braided polyester surgical suture, and pre-assembled on a disposable inserter." This is a physical implant and its delivery system.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information contains no mention of analyzing samples, performing tests, or providing diagnostic information based on biological samples.
The Stryker XCEL Anchor is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker XCEL Anchor is intended for use in securing soft tissue to bone in such procedures as:
- Shoulder: Bankart repair, SLAP lesion repair, Rotator cuff repair, Capsular shift repair, Biceps tenodesis, Acromio-clavicular separation
- Elbow: Biceps tendon reattachment
- Foot & Ankle: Achilles tendon repair/reconstruction, Lateral stabilization, Medial stabilization
- Knee: Medial collateral ligament repair, Lateral collateral ligament repair, Joint capsule closure to anterior proximal tibia, Posterior oblique ligament or joint capsule to tibia repair, Extra capsular reconstruction/ITB tenodesis, Patellar ligament and tendon avulsion repairs
The Stryker XCEL Anchor is intended for single-use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with non-absorbable, braided polyester surgical suture, and pre-assembled on a disposable inserter. Stryker instrumentation, drill and soft-tissue guide/drill guide, will be used to install the Stryker XCEL Anchor.
The Stryker XCEL Anchor System will be provided pre-assembled, sterile for single-use applications (ASTM 4169). The device will be sterilized by Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10-6. The device is biocompatible per ISO 10993 and G95-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Foot & Ankle, Knee
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 subject device was shown to have substantially equivalent performance when compared to the predicate device.
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
Image /page/0/Picture/0 description: The image shows the logo for Stryker Endoscopy. The word "Stryker" is in a bold, sans-serif font, with the "S" stylized to look like a medical symbol. The word "Endoscopy" is in a smaller, sans-serif font and is located below the word "Stryker". There is a registered trademark symbol to the right of the word "Stryker".
K0230/3
Page 11
FEB 2 6 2003
SUMMARY OF SAFETY AND EFFECTIVENESS
De ice Name
Classification Name:
Common and Usual Name: Proprietary Name:
Smooth or Threaded Metallic Bone Fixation Fasteners: 21 CFR §888.3040, Class II Suture Anchor (MAI) Stryker XCEL Anchor System
Prodicate Device
Mi ek Panalok 3.5mm Absorbable Anchor System, (#K970896), currently marketed by Mitek Prc ducts/lithicon (Westwood, MA).
Su nmarv
Th s summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
Th > Stryker XCEL Anchor System is intended to be implanted within a pre-drilled bone hole site and pr vide a means for firmly securing soft tissue to bone using suture. The use of suture anchors is common in >rthopedic surgery, and has been well published in professional journals such as Arthroscopy: The Jo irnal of Arthroscopic and Related Surgery.
The Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with nonab torbable, braided polyester surgical suture, and pre-assembled on a disposable inserter. Stryker in: trumentation, drill and soft-tissue guide/drill guide, will be used to install the Stryker XCEL Anchor.
The Stryker XCEL Anchor System will be provided pre-assembled, sterile for single-use applications (ASTM 4169). The device will be sterilized by Ethylene oxide (EN550), including limits for Ethylene O: ide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per IS 3-10993 and G95-1. The Stryker XCEL Anchor is substantially equivalent in intended use, safety, and ef icacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.
Tl e Stryker XCEL Anchor System is considered substantially equivalent to the Mitek Panalok 3.5mm A' sorbable Anchor System.
Contact:
Date: December 11, 2002
Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2000 x.2259
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
FEB 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K023013
Trade/Device Name: Stryker XCEL Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic fixation fastener Regulatory Class: II Product Code: HWC Dated: December 11, 2002 Received: December 12, 2002
Dear Ms. Miller:
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 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.
2
Page 2 - Ms. Alisa Miller
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 (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
De zember 11, 2002
510(k) Number: K023013
INDICATION FOR USE:
The Stryker XCEL Anchor is intended for use in securing soft tissue to bone in such procedures as:
| Shoulder: | Elbow: | Foot & Ankle: |
|---|---|---|
| Bankart repair | Biceps tendon reattachment | Achilles tendon repair/reconstruction |
| SI AP lesion repair | Lateral stabilization | |
| Rotator cuff repair | Medial stabilization | |
| Capsular shift repair | ||
| Biceps tenodesis | ||
| Acromio-clavicular separation |
Knee:
Medial collateral ligament repair La teral collateral ligament repair Joint carsule closure to anterior proximal tibia P sterior oblique ligament or joint capsule to tibia repair Extra capsular reconstruction/ITB tenodesis P: tellar ligament and tendon avulsion repairs
The Stryker XCEL Anchor is intended for single-use only.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODF)
Mark M
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
Number K023013
Over-the-Counter Use No
Prescription Use (Fer 21 CFR 801.109)
OR