(254 days)
VERTE-STACK® Spinal System (K031780)
No
The summary describes a physical implant and associated surgical tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) to alleviate discogenic back pain and provide stabilization to the spine.
No
Explanation: The device is described as a "vertebral body spacer" used for interbody fusion and provides structural support. Its purpose is treatment (fusion) rather than diagnosis.
No
The device description clearly states the system consists of vertebral body spacers made of PEEK and tantalum markers, along with instrumentation for implantation. These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD)". This describes a surgical implant used to treat a physical condition.
- Device Description: The device is described as "vertebral body spacers" and "instrumentation that enables the surgeon to implant the devices". This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. The "X-ray or other imaging" is used to determine the position of the implant, not to diagnose the patient's DDD.
- Performance Studies: The performance studies listed are related to the mechanical properties and stability of the implant (compression, shear, subsidence), which are relevant for a surgical device, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The subject TELAMON® PEEK Spinal System consists of vertebral body spacers which can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implant allows them to be packed with autogenous bone graft material. The TELAMON® PEEK Spinal System also includes instrumentation that enables the surgeon to implant the devices via an open or a minimally invasive posterior approach.
The device sizes are available in various height and lordotic angle options. The implant devices are manufactured from medical grade polyetheretherketone (PEEK - OPTIMA® LT1) per ASTM F2026 and also contain tantalum markers per ASTM F-560 so that the position of the implant can be determined on X-ray or other imaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or other imaging (for determining implant position)
Anatomical Site
lumbar or lumbo-sacral vertebral bodies (L2 to S1)
Indicated Patient Age Range
skeletally mature
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 following pre-clinical studies were conducted using worst case TELAMON® devices: static and dynamic compression; and static and dynamic compression shear per ASTM F2077-03; and subsidence per ASTM F2267-04. The results of these studies were found to be substantially equivalent to legally marketed devices.
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.
VERTE-STACK® Spinal System (K031780)
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.
CAPSTONE® Spinal System (K073291), CRESCENT™ Spinal System (K094025), LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015), RAY® Threaded Fusion Cage (P950019), Brantigan Lumbar I/F CAGE® (P960025)
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
§ 888.3080 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
K110562 Page 1 of 2
NOV - 9 2011
TELAMON® PEEK Spinal System Interbody Fusion Device 510(k) Summary February 2011
Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Regina Holmes Contact: Senior Regulatory Affairs Specialist
II. Proprietary Trade Name: TELAMON® Spinal System
Classification Name: Intervertebral Fusion Device with Bone Graft, Lumbar
Product Code: MAX (21 CFR 888.3080)
Common Name: Interbody Fusion Device
III. Product Description
The subject TELAMON® PEEK Spinal System consists of vertebral body spacers which can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implant allows them to be packed with autogenous bone graft material. The TELAMON® PEEK Spinal System also includes instrumentation that enables the surgeon to implant the devices via an open or a minimally invasive posterior approach.
The device sizes are available in various height and lordotic angle options. The implant devices are manufactured from medical grade polyetheretherketone (PEEK - OPTIMA® LT1) per ASTM F2026 and also contain tantalum markers per ASTM F-560 so that the position of the implant can be determined on X-ray or other imaging.
IV. Indications for Use
The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
1
These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
V. Performance Data
.
The following pre-clinical studies were conducted using worst case TELAMON® devices: static and dynamic compression; and static and dynamic compression shear per ASTM F2077-03; and subsidence per ASTM F2267-04. The results of these studies were found to be substantially equivalent to legally marketed devices.
VI. Substantial Equivalence
Documentation was provided which demonstrated that the subject device is substantially equivalent to the following currently marketed devices: VERTE-STACK® Spinal System (K031780); CAPSTONE® Spinal System (K073291); CRESCENT™ Spinal System (K094025); LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015); RA Y® Threaded Fusion Cage (P950019); and Brantigan Lumbar I/F CAGE® (P960025).
VII. Conclusion
When compared to the predicate devices, it was determined that the subject device is substantially equivalent based on the following factors:
- . The device designs are similar in shape, size, and footprint range.
- . The devices share the same intended use.
- The devices are manufactured from the same material and under go the same . sterilization methods.
- The results of mechanical testing are comparable to the predicates and demonstrate . that the subject device is as safe and effective as other legally marketed devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 9 2011
Medtronic Sofamor Danek % Ms. Regina Holmes Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K110562
Trade/Device Name: TELAMON® PEEK Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 13, 2011 Received: October 14, 2011
Dear Ms. Holmes:
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
3
Page 2 - Ms. Regina Holmes
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); 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Eiriel Keith
-fo Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K110562
Device Name: TELAMON® PEEK Spinal System
Indications for Use:
The TELAMON® PEEK Spinal System is indicated for interbody fusion with autogenous bone graft in patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft and are intended for bilateral placement in the lumbar spine. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine.
Prescription Use × (Part 21 CFR 801 Subpart D)
510(k) Number_
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 |
| 510(k) Number | K110562 |
|---|---|
| --------------- | --------- |