(31 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a spinal implant and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
The device is a vertebral body replacement indicated to replace damaged or unstable vertebral bodies, restore height, and achieve decompression, which are all therapeutic actions.
No.
The document describes the device as a vertebral body replacement used to restore height and achieve decompression, not to diagnose a condition.
No
The device description clearly states it is a "vertebral body replacement" and a "PEEK Spacer," which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement intended for surgical implantation in the spine to replace damaged or unstable vertebral bodies. This is a surgical implant, not a diagnostic test performed on a sample outside the body.
The information provided focuses on the device's function as a structural implant and its use in surgical procedures, which is consistent with a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Stryker Spine AVS PL PEEK Spacer is a vertebral body replacement indicated for use in the thoraco-lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedure due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine AVS PL PEEK Spacer include, but are not limited to, Stryker Spine plate or rod systems (XIA, Spiral Radius 90D, and Trio).
Product codes
MQP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoraco-lumbar spine (T1-L5)
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)
Documentation is provided which demonstrates the Stryker Spine AVS™ PL PEEK Spacer to be substantially equivalent to its predicate devices in terms of its material, sizes, and indications for use. Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed for the Stryker Spinal AVS™ PL PEEK Spacer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040731, K042571, K031780, K003043, K003709
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
510(k) Premarket Notification
APR J 1 2005
510(k) Summary of Safety and Effectiveness:
Stryker Spine AVS™ PL PEEK Spacer
| Submitter: | Stryker Spine
2 Pearl Court
Allendale, New Jersey 07401 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Simona Voic
Regulatory Affairs Project Manager
Phone: 201-760-8145
FAX: 201-760-8345
Email: Simona.Voic@stryker.com |
| Date Prepared | March 9, 2005 |
| Trade Name | Stryker Spine AVSTM PL PEEK Spacer |
| Classification Name
and Number | Spinal Vertebral Body Replacement Device,
21 CFR 888.3060 |
| Product Code | MQP |
| Purpose of the
premarket notification | The purpose of this premarket notification is to add indications and
new implant sizes to the previously cleared Stryker Spine Vertebral
Spacer. |
| Predicate Devices | 1) Stryker Spine Vertebral Spacer (K040731)
2) Stryker Spine AVSTM TL PEEK Spacer (K042571)
3) Medtronic Sofamor Danek VERTE-STACKTM Spinal
System (K031780)
4) DePuy Surgical Titanium MeshTM (K003043)
5) Surgical Dynamics Mesh Cage System (K003709) |
| Intended Use | The Stryker Spine AVSTM PL PEEK Spacer is a vertebral body
replacement indicated for use in the thoraco-lumbar spine (T1-L5) to
replace a collapsed, damaged, or unstable vertebral body resected or
excised during partial and total vertebrectomy procedure due to
tumor or trauma, to achieve anterior decompression of the spinal
cord and neural tissues, and to restore the height of a collapsed |
| Summary of the
Technological
Characteristics | vertebral body.
It is recommended to pack bone graft material inside the implant.
The Stryker Spine AVS™ PL PEEK Spacer is intended for use with
supplemental fixation. The supplemental fixation systems that may
be used with the Stryker Spine AVS™ PL PEEK Spacer include, but
are not limited to, Stryker Spine plate or rod systems (XIA, Spiral
Radius 90D, and Trio). |
| | Documentation is provided which demonstrates the Stryker Spine
AVS™ PL PEEK Spacer to be substantially equivalent to its
predicate devices in terms of its material, sizes, and indications for
use. Testing to demonstrate compliance with FDA's Guidance for
Spinal System 510(k)'s May 3, 2004 was completed for the Stryker
Spinal AVS™ PL PEEK Spacer. |
Page 1 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health and Human Services.
APR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Simona Voic Regulatory Affairs Project Manager Stryker Spine 2 Pearl Court Allendale, New Jersey 07401
Re: K050624
K050624
Trade/Device Name: Stryker Spine AVS™ PL PEEK Spacer System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: March 9, 2005 Received: March 11, 2005
Dear Ms. Voic:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section > ro(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substant in interested in for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for tuse stated in the encrosure) to regars names date of the Medical Device American so to commerce prior to May 26, 1776, the characterial and of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Analystics (RMA) devices that have been reciassified in docordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosmetic Act (Act) that do not roquire approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the general magatestion, listing You may, merelove, market the dovices, belyer to the one of the sensual registration, listing of general controls provisions of the free meralies sequilibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (secrated in the Existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional connounce "Entroling cargers" on addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Ood of reasons concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualice of a subscance complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decertimation that your assess of a secret by other Federal agencies and ligit or any Federal statures and regularions daministered of not limited to: registration and listing (21 let comply with an the Act 3 requirements) news 801); good manufacturing practice requirements as setsen CFR Part 807); labeling (21 CFR Part 001); good frankat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
3
Page 2 - Ms. Simona Voic
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stypt Plurle
Miriam Provost, Ph.D. Acting 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:_Stryker_Spine AVS™ PL_PEEK_Spacer
Indications For Use:
The Stryker Spine AVS™ PL PEEK Spacer is a vertebral body replacement indicated The Otlyker Spine / N C / 1-L5) to replace a collapsed, damaged, or for use in the thoraco lumbul opino ( + = => > > > > > unstable vertebrar body rooooted of the nechieve anterior decompression of the spinal procedures due to tradinal to tradinal to theight of a collapsed vertebral body. oord and nodial to pack bone graft material inside the implant.
The Stryker Spine AVS™ PL PEEK Spacer is intended for use with supplemental fixation. The supplemental fixation systems that may be used with the Stryker Spine fixation: The supplicinal hiation of Jimited to, Stryker Spine plate rod or rod systems (XIA, Spiral Radius 90D, and Trio).
Prescription Use × (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)
Stent Clarke
on-() Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K050624