(254 days)
Not Found
No
The summary describes physical interbody fusion devices made of PEEK and titanium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
This device is designed for cervical and lumbar interbody fusion procedures to treat disc disease and stabilize the spine, which are therapeutic interventions.
No
The devices described are interbody fusion implants (cages, screws) designed to provide support and correction during spinal fusion surgeries. Their function is structural and mechanical, facilitating fusion, rather than diagnosing conditions.
No
The device description clearly states that the devices are physical implants made of PEEK and titanium alloy, intended for surgical implantation. This is not a software-only device.
Based on the provided text, these devices are not In Vitro Diagnostic (IVD) devices.
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: The descriptions clearly state that these devices are implants (cages, screws) designed to be surgically inserted into the spine for fusion procedures. They are physical devices used within the body, not for testing samples outside the body.
- Intended Use: The intended use is for cervical and lumbar interbody fusion procedures to treat conditions like cervical disc disease and degenerative disc disease. This involves surgical intervention and implantation, not laboratory testing of specimens.
Therefore, these devices fall under the category of surgical implants or medical devices used for treatment, not IVD devices.
N/A
Intended Use / Indications for Use
a. ANATOMIC PEEK Cervical Fusion Implants
The ANATOMIC PEEK device is indicated for 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. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK device is also required to be used with autograft and is to be implanted via an open, anterior approach.
b. CORNERSTONE® PSR Cervical Fusion Implants
The CORNERSTONE® PSR device is indicated for 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. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.
PEEK PREVAIL™ Cervical Interbody Device
The PEEK PREVAIL™ Cervical Interbody Device 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 PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
d. CAPSTONE® CONTROL Spinal System Implants
The CAPSTONE CONTROLTM Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
CLYDESDALE® Spinal System Implants e.
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. 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 nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.
f. CRESCENT® Spinal System (PEEK) Implants
The CRESCENT® Spinal System is indicated for interbody fusion with . autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
g. SOVEREIGN® Spinal System Implants
The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 nonoperative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.
When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.
h. TELAMON® PEEK Spinal System Implants
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 nonoperative treatment.
These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Product codes
ODP, OVE, MAX, OVD
Device Description
The 510(k) submission addresses an update for Medtronic Sofamor Danek's PEEK Interbody Fusion Devices to provide appropriate MRI safety labeling. The subject devices are various cervical and lumbar interbody fusion implants.
a. ANATOMIC PEEK Cervical Fusion Implants: These are PEEK cages of various widths and heights, designed for insertion between cervical vertebral bodies for support and correction during fusion surgeries. They are hollow, allowing for autogenous bone graft packing, and are intended for open anterior implantation with supplemental fixation and autogenous bone graft.
b. CORNERSTONE® PSR Cervical Fusion Implants: These are PEEK cages of various widths and heights, similar to ANATOMIC PEEK implants, for cervical interbody fusion. They are hollow for bone graft packing and are implanted via an open anterior approach with supplemental instrumentation.
c. PEEK PREVAIL™ Cervical Interbody Device: An intervertebral body fusion device with internal screw fixation, featuring an "I-Beam" shape and a 2-screw midline configuration. The screws stabilize the vertebral body and prevent implant expulsion. It is radiolucent, uses autograft in its interior space, and is made from PEEK with tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws (ZEPHIR® Anterior Cervical Screws) are Titanium Alloy.
d. CAPSTONE® CONTROL Spinal System Implants: PEEK cages of various widths and heights with Tantalum markers, designed for insertion between lumbar or lumbosacral vertebral bodies for support and correction during lumbar interbody fusion surgeries. They are hollow for autograft packing and are used with supplemental instrumentation via open or minimally invasive posterior or transforaminal approaches.
e. CLYDESDALE® Spinal System Implants: PEEK cages of various widths and heights with Tantalum markers, designed for lateral insertion between lumbar or lumbosacral vertebral bodies for lumbar interbody fusion. They are hollow for autograft packing and are used with supplemental instrumentation.
f. CRESCENT® Spinal System (PEEK) Implants: PEEK cages of various widths and heights with Tantalum markers, designed for insertion between lumbar or lumbosacral vertebral bodies for lumbar interbody fusion. They are hollow for autograft packing and can be implanted via posterior, transforaminal, or lateral approaches (open or minimally invasive) with supplemental instrumentation.
g. SOVEREIGN® Spinal System Implants: An intervertebral body fusion device with internal screw fixation. It is lens-shaped with three holes for titanium screws (fixed or variable angle). The fixed angle provides an interference fit, while the variable angle allows slight screw angulation. It is radiolucent, uses autogenous bone graft, and is made from PEEK with tantalum radiopaque markers. An accompanying cover plate prevents screw backout and must be used with variable angle screws.
h. TELAMON® PEEK Spinal System Implants: PEEK cages of various widths and heights with Tantalum markers, designed for insertion between lumbar or lumbosacral vertebral bodies for lumbar interbody fusion. They are hollow for autograft packing and can be implanted via an open or minimally invasive posterior approach with supplemental instrumentation.
All subject devices are generally manufactured from PEEK and tantalum materials and are intended for intervertebral body fusion procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C3 disc to C7-T1 disc), Lumbar spine (L2 to S1), Lumbosacral spine (L2 to S1)
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
Non-clinical testing was performed in accordance with FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment."
Study Type: Non-clinical testing for MR compatibility.
Sample Size: Worst case implants were tested.
Key Results: The subject devices were determined to be MR conditional based on testing according to ASTM F2503, ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182.
Standalone Performance: The devices underwent testing for magnetically induced displacement force, magnetically induced torque, MR image artifacts, and radio frequency induced heating.
Key Metrics
Not Found
Predicate Device(s)
K112444, K100214, K111264, K073285, K094042, K113252, K030327, K120368, K113528, K100175, K083026, K094025, K091813, K110063, K110562
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
510(k) SUMMARY MEDTRONIC Sofamor Danek MRI Update for PEEK Interbody Fusion Devices July 2012
I. Medtronic Sofamor Danek, Company: USA Inc. 1800 Pyramid Place Memphis, Tennessee 38132 (901) 396-3133 II. Contact: Becky Ronner Regulatory Affairs Specialist Telephone: (901) 399-2757 Fax: (901) 346-9738
III. Proprietary Trade Name: Cervical Interbody Fusion Devices ANATOMIC PEEK Cervical Fusion System CORNERSTONE® PSR Cervical Fusion System PEEK PREVAIL® CERVICAL INTERBODY DEVICE
Lumbar Interbody Fusion Devices CAPSTONE® CONTROL Spinal System CLYDESDALE® Spinal System CRESCENT® Spinal System (PEEK) SOVEREIGN® Spinal System TELAMON® PEEK Spinal System
IV. Common &Classification Names: Cervical & Lumbar Interbody Fusion Devices
Class:
II
MAR 2 2 2013
1
Product Code:
| ODP (21 CFR
888.3080) | ANATOMIC PEEK Cervical Fusion
System
CORNERSTONE® PSR Cervical
Fusion System |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| OVE (21 CFR
888.3080) | PEEK PREVAIL® CERVICAL
INTERBODY DEVICE |
| MAX (21 CFR
888.3080) | CAPSTONE® CONTROL Spinal
System
CLYDESDALE® Spinal System
CRESCENT® Spinal System
(PEEK)
TELAMON® PEEK Spinal System |
| OVD (21 CFR
888.3080) | SOVEREIGN® Spinal System |
V. Description:
a. ANATOMIC PEEK Cervical Fusion Implants
The ANATOMIC PEEK Cervical Fusion Implants consists of cages of various widths and heights which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. These implants are manufactured from implant grade polyetheretherketone (PEEK). The hollow geometry of the implants allows them to be packed with autogenous bone graft in cervical interbody fusion procedures. The ANATOMIC PEEK devices are intended to be implant via an open anterior approach and used with supplemental fixation and autogenous bone graft.
b. CORNERSTONE® PSR Cervical Fusion Implants
The CORNERSTONE® PSR Cervical Fusion Implants consist of cages of various widths and heights, which can be inserted between two cervical vertebral bodies to give support and correction during cervical interbody fusion surgeries. These implants are manufactured from implant grade PEEK. The hollow geometry of the implants allows them to be packed with autogenous bone graft in cervical fusion procedures. The CORNERSTONE® PSR device is to be used with supplemental instrumentation and is to be implanted via an open, anterior approach.
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c. PEEK PREVAIL™ Cervical Interbody Device
The PEEK PREVAIL™ Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is "I-Beam" shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior space of the product is to be used with autograft.
The PEEK PREVAIL™ Cervical Interbody device implant is manufactured from PEEK and contains tantalum radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR® Anterior Cervical Screws) are manufactured from Titanium Alloy.
d. CAPSTONE® CONTROL Spinal System Implants
The CAPSTONE CONTROL™ Spinal System Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE CONTROL™ Spinal System Implants are to be used with supplemental instrumentation and are to be implanted via an open or minimally invasive, posterior or transforaminal approach.
e. CLYDESDALE® Spinal System Implants
The CLYDESDALE® Spinal System Implants consist of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted via a lateral approach between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CLYDESDALE® Spinal System Implants are to be used with supplemental instrumentation.
3
f. CRESCENT® Spinal System (PEEK) Implants
The CRESCENT® Spinal System Implants consist of PEEK cages of various widths and heights which include Tantalum markers. These implants can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants may be implanted via a posterior, transforaminal or lateral approach and the procedure may be open or minimally invasive. The CRESCENT® Spinal System Implants are to be used with supplemental instrumentation.
g. SOVEREIGN® Spinal System Implants
The SOVEREIGN® Spinal System Implants are an intervertebral body fusion devices with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with three holes for placement of titanium screws. The SOVEREIGN® Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted.
The SOVEREIGN® Spinal System interbody device is manufactured from PEEK and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.
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h. TELAMON® PEEK Spinal System Implants
The TELAMON® PEEK Spinal System Implants consist of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. These implants may be implanted via an open or a minimally invasive posterior approach. The TELAMON® PEEK Spinal System Implants are to be used with supplemental instrumentation.
VI. Indications for Use:
a. ANATOMIC PEEK Cervical Fusion Implants
The ANATOMIC PEEK device is indicated for 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. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK device is to be used with supplemental fixation. The ANATOMIC PEEK device is also required to be used with autograft and is to be implanted via an open, anterior approach.
b. CORNERSTONE® PSR Cervical Fusion Implants
The CORNERSTONE® PSR device is indicated for 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
5
radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.
PEEK PREVAIL™ Cervical Interbody Device ﻦ
The PEEK PREVAIL™ Cervical Interbody Device 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 PEEK PREVAIL™ Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
d. CAPSTONE® CONTROL Spinal System Implants
The CAPSTONE CONTROLTM Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants
6
are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
CLYDESDALE® Spinal System Implants e.
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for patients diagnosed with degenerative disc disease (DDD) at one or two contiguous levels from L2 to SI. 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 nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.
f. CRESCENT® Spinal System (PEEK) Implants
The CRESCENT® Spinal System is indicated for interbody fusion with . autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
g. SOVEREIGN® Spinal System Implants
The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain
7
with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. These implants may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.
When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.
h. TELAMON® PEEK Spinal System Implants
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 nonoperative treatment.
These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
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VII. Summary of the Technological Characteristics:
The purpose of this bundled 510(k) application is to provide appropriate MRI safety labeling for the subject devices, while also providing MRI technologists with a method of concluding whether an MRI scan can be performed on the device and specific instructions on how to perform the scan. The systems in this 510(k) submission have been determined to be MR conditional per ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
The labeling that is being proposed has previously been cleared by FDA in submission K I 10063 for SOVEREIGN® Spinal System Implants. All the subject devices within this bundled submission have the same fundamental technology. They are intended to provide correction and stabilization during intervertebral body fusion procedures for treatment of degenerative disc disease. They are all generally manufactured from the same PEEK and tantalum materials and have been designed to be used with autogenous bone graft. There have been no changes to the design, to the material or the indications of the subject devices and are therefore identical to their predicates.
The design/specifications of the subject devices are not being addressed. No changes have occurred for the devices in the subject product families which are considered substantially equivalent to and previously cleared under previous 510(k) submissions such as:
- a. ANATOMIC PEEK Cervical Fusion System K112444 (SE 11/15/2011)
- b. CORNERSTONE® PSR Cervical Fusion System K100214 (SE 06/25/2010), K111264 (SE 10/12/2011)
- c. PEEK PREVAIL® Cervical Interbody Device K073285 (SE 05/15/2008), K094042 (SE 06/30/2010), K113252 (SE 01/17/2012), K030327(SE 02/26/2003)
- d. CAPSTONE® CONTROL Spinal System K120368 (04/09/2012)
9
- e. CLYDESDALE® Spinal Svstem K113528 (SE 12/20/2011), K100175 (SE 06/02/2010), K083026 (SE 12/29/2008)
- f. CRESCENT® Spinal System (PEEK) K094025 (SE 04/26/2010)
- g. SOVEREIGN® Spinal System K091813 (SE 11/17/2009), K110063 (SE 10/04/2011)
- h. TELAMON® PEEK Spinal System K110562 (SE 11/09/2011)
IX. Discussion of Non-Clinical Testing:
In accordance FDA Guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" testing has been completed on the worst case implants. The following testing has been completed and provided a determination that the subject devices in this 510(k) submission have been determined to be MR conditional:
- o ASTM F2052 "Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment"
- o ASTM F2213 "Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment"
- o ASTM F2119 "Standard test method for evaluation of MR image artifacts from passive implants"
- ASTM F2182 "Standard test method for measurement of radio frequency o induced heating on or near passive implant during magnetic resonance imaging"
- ASTM F2503 "Standard practice for marking medical devices and other o items for safety in the magnetic resonance environment"
X. Conclusion:
Non-clinical testing in accordance with the standards listed above was completed along with a risk analysis. Based on the test results and additional
10
supporting documentation provided within this pre-market notification, Medtronic believes that the subject devices demonstrate substantial equivalence to the listed predicate device and should be labeled as MR Conditional in accordance with ASTM F2503 – "Standard practice for marking medical devices and other items for safety in the magnetic resonance environment'.
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Image /page/11/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is represented by a triple-stranded helix.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2013
Medtronic Sofamor Danek USA, Incorporated % Ms. Becky Ronner Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K122037
Trade/Device Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class H Product Code: MAX, ODP, OVE, OVD Dated: February 20, 2013 Received: February 21, 2013
Dear Ms. Ronner:
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 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
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Page 2 - Ms. Becky Ronner
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/ucm1.15809.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,
Image /page/12/Picture/6 description: The image shows the name "Erin I.D.Keith" in a stylized font. The letters "I.D.K" are designed with a layered, geometric pattern, giving them a unique visual texture. The rest of the letters are in a bold, sans-serif font, creating a contrast with the central part of the name.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
13
510(k) Number (if known): K122037
Device Name: ANATOMIC PEEK CERVICAL FUSION SYSTEM
Indications for Use:
The ANATOMIC PEEK CERVICAL FUSION SYSTEM is indicated for 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. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is to be used with any cleared supplemental fixation device for cervical. The ANATOMIC PEEK CERVICAL FUSION SYSTEM is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach."
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)
14
510(k) Number (if known): K122037
Device Name: CORNERSTONE® PSR Cervical Fusion System
Indications for Use:
The CORNERSTONE® PSR device is indicated for 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. This device is to be used in patients who have had six weeks of non-operative treatment. The CORNERSTONE® PSR device is to be used with supplemental fixation. The CORNERSTONE® PSR device is also required to be used with autograft.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
15
510(k) Number (if known): __K122037
Device Name: PEEKPREVAIL® Cervical Interbody Device
Indications for Use:
The PEEK PREVAIL™ Cervical Interbody Device 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 PEEK PREVAILTM Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK PREVAIL™ Cervical Interbody Device implants are to be used with autograft and implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative 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)
16
510(k) Number (if known): _K122037
Device Name: CAPSTONE® CONTROL Spinal System
Indications for Use:
The CAPSTONE CONTROL™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
17
510(k) Number (if known): K122037
Device Name: CLYDESDALE® Spinal System
Indications for Use:
The CLYDESDALE® Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE® Spinal System is used for 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 nonoperative treatment. These implants may be implanted via a minimally invasive lateral approach.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
18
510(k) Number (if known): _K122037
Device Name: CRESCENT® Spinal System (PEEK)
Indications for Use:
The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two 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 devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.
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)
19
510(k) Number (if known): K122037
Device Name: SOVEREIGN® Spinal System
Indications for Use:
The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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 may be implanted via a laparoscopic or an open anterior approach.
The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation.
When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with the three titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than three or none of the provided screws, then additional supplemental fixation for use in the lumbar spine must be used to augment stability.
Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)
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)
20
510(k) Number (if known): K122037
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 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. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
Prescription Use x (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)