(224 days)
No
The document describes a physical implant (cage and screws) and its mechanical testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for anterior cervical interbody fusion procedures to treat cervical disc disease, which involves relieving symptomatic nerve root and/or spinal cord compression, indicating a therapeutic purpose.
No
Explanation: The device is an interbody fusion cage designed to treat cervical disc disease by promoting fusion and providing structural support, not to diagnose medical conditions.
No
The device description clearly details a physical implant made of PEEK and titanium, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Stryker Spine AVS® Anchor-C Cervical Cage System is a physical implant designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic information derived from in vitro testing.
Therefore, the device described is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The AVS® Anchor-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior approach.
The AVS® Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Product codes
ODP
Device Description
The AVS® Anchor-C Cervical Cage is a hollow, rectangular-shaped PEEK Optima® LT1 (per ASTM F2026) cage assembled to a titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) plate and has one tantalum marker (per ASTM F560). It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to adapt to varying patient anatomies. The PEEK Optima® LTI cage portion consists of one closed pocket for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used exclusively with the internal supplemental fixation provided (AVS® Anchor-C Fixation Screws). The AVS® Anchor-C Fixation Screws are constructed from titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832-3) and possess clips (also constructed from titanium alloy Ti6Al4V per ASTM F136 and ISO 5832-3) that mate with internal features located within the AVS® Anchor-C Cervical Cage. Once fully seated into the holes, the screws are designed to lock into the titanium plate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one level from the C2-C3 disc to the C7-T1 disc
Indicated Patient Age Range
skeletally mature patients
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)
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AVS® Anchor-C implant system and demonstrated substantially equivalent performance to the identified predicate device systems.
The following mechanical tests were performed:
• Static Compression (per ASTM F2077)
• Dynamic Compression (per ASTM F2077)
• Static Compression Shear (per ASTM F2077)
• Dynamic Compression Shear (per ASTM F2077)
• Static Torsion (per ASTM F2077)
• Dynamic Torsion (per ASTM F2077)
• Expulsion (per ASTM F04-25-02-02 Draft)
• Subsidence (per ASTM F2267)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LDR MC+, 510(k) # K091088, Surgicraft STALIF C, 510(k) #K072415, Depuy Bengal #K081917, Spinal Elements Crystal #K073351, Zimmer BAK/C # P980048, Medtronic AFFINITY #P000028
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
12102606
Stryker Spine AVS® Anchor-C Cervical Cage System
Traditional S10(k) Premarket Notification
APR 2 2 2011
・j
| 510(k) Summary: AVS® Anchor-C Cervical Cage System | ||
|---|---|---|
| Submitter: | Stryker Spine | |
| 2 Pearl Court | ||
| Allendale, New Jersey 07401 | ||
| Contact Person | Ms. Kimberly Lane | |
| Sr. Regulatory Affairs Specialist | ||
| Phone: 201-760-8215 | ||
| Fax: 201-760-8415 | ||
| Email: kimberly.lane@stryker.com | ||
| Date Prepared | April 19, 2011 | |
| Trade Name | AVS® Anchor-C Cervical Cage System | |
| Proposed Class | Class II | |
| Classification Name | ||
| and Number | Intervertebral body fusion device, 21 CFR 888.3080 | |
| Product Code | ODP | |
| Predicate Devices | The AVS® Anchor-C Cervical Cage System was shown to be | |
| substantially equivalent to the devices listed below: | ||
| ● LDR MC+, 510(k) # K091088 | ||
| ● Surgicraft STALIF C, 510(k) #K072415 | ||
| ● Depuy Bengal #K081917 | ||
| ● Spinal Elements Crystal #K073351 | ||
| ● Zimmer BAK/C # P980048 | ||
| ● Medtronic AFFINITY #P000028 | ||
| Device Description | The AVS® Anchor-C Cervical Cage is a hollow, rectangular- | |
| shaped PEEK Optima® LT1 (per ASTM F2026) cage assembled | ||
| to a titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832- |
- plate and has one tantalum marker (per ASTM F560). It is
intended for use as an interbody fusion device and is offered in a
variety of heights, footprints, and lordotic angles to adapt to
varying patient anatomies. The PEEK Optima® LTI cage | |
| 510(k) Summary: AVS® Anchor-C Cervical Cage System | | portion consists of one closed pocket for graft containment and
has serrations on the superior and inferior surfaces of the cage.
The implant is designed to be used exclusively with the internal
supplemental fixation provided (AVS® Anchor-C Fixation
Screws). The AVS® Anchor-C Fixation Screws are constructed
from titanium alloy Ti6Al4V (per ASTM F136 and ISO 5832- - and possess clips (also constructed from titanium alloy
Ti6Al4V per ASTM F136 and ISO 5832-3) that mate
with internal features located within the AVS® Anchor-C
Cervical Cage. Once fully seated into the holes, the screws are
designed to lock into the titanium plate. |
| Intended Use | | The Stryker Spine AVS® Anchor-C Cervical Cage System is
indicated for anterior cervical interbody fusion procedures in
skeletally mature patients with cervical disc disease at one level
from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is
defined as intractable radiculopathy and/or myelopathy with
herniated disc and/or osteophyte formation on posterior vertebral
endplates producing symptomatic nerve root and/or spinal cord
compression confirmed by radiographic studies. The AVS®
Anchor-C Cervical Cage is to be used with autogenous bone
graft and implanted via an open, anterior approach.
The AVS® Anchor-C Cervical Cage must be used with the
internal screw fixation provided by AVS® Anchor-C Fixation
Screws. This cervical device is to be used in patients who have
had six weeks of non-operative treatment. |
| Summary of the
Technological
Characteristics | | The subject AVS® Anchor-C implant system and the predicates
share similar design features:
• Graft windows for packing autogenous bone |
| 510(k) Summary: AVS® Anchor-C Cervical Cage System | | |
| • | Serrations on the superior and inferior surfaces | |
| • | Comparable heights, widths, depths, and lordotic angles | |
| | Testing in compliance with FDA's June 12, 2007 "Class II
Special Controls Guidance Document: Intervertebral Body
Fusion Device" was performed for the AVS® Anchor-C implant
system and demonstrated substantially equivalent performance
to the identified predicate device systems. | |
| | The following mechanical tests were performed: | |
| • | Static Compression (per ASTM F2077) | |
| • | Dynamic Compression (per ASTM F2077) | |
| • | Static Compression Shear (per ASTM F2077) | |
| • | Dynamic Compression Shear (per ASTM F2077) | |
| • | Static Torsion (per ASTM F2077) | |
| • | Dynamic Torsion (per ASTM F2077) | |
| • | Expulsion (per ASTM F04-25-02-02 Draft) | |
| • | Subsidence (per ASTM F2267) | |
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K102606
Stryker Spine AVS® Anchor-C Cervical Cage System
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Image /page/3/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 eagle or bird symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine % Ms. Kimberly Lane Senior Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
ട്ട് -
K102606 Trade/Device Name: Stryker Spine AVS® Anchor-C Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: April 4, 2011 Received: April 5, 2011
Dear Ms. Lane:
Re:
This letter corrects our substantially equivalent letter of April 22, 2011.
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 (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 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
4
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); medical device reporting (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.
Sincerely yours,
Mark A. Milbersen
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Stryker Spine AVS® Anchor-C Cervical Cage System
Traditional 510(k) Premarket Notification
Indications for Use
K102606 510(k) Number (if known): K
Device Name: Stryker Spine AVS® Anchor-C Cervical Cage System
Indications For Use:
The Stryker Spine AVS® Anchor-C Cervical Cage System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C disc to the C7-T1 disc. Cervical disc disease is defined as intractable radioulopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographics producting synoding synador-C Cervical Cage is to be used with autogenous bone graft and implanted via an open, anterior annonce
The AVS Anchor-C Cervical Cage must be used with the internal screw fixation provided by AVS® Anchor-C Fixation Screws. This cervical device is to be used in patients who have had six weeks of nonoperative treatment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIO2666 510(k) Number.
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