(81 days)
No
The summary describes a spinal implant system made of titanium or stainless steel rods, screws, and hooks. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are based on mechanical testing and retrospective clinical data, not AI/ML model validation.
Yes.
The device is described as an implantable system for spinal stabilization during fusion procedures, used to treat various spinal conditions, which directly indicates a therapeutic purpose.
No
This device is an implantable surgical system used to stabilize the spine during fusion procedures, not for diagnostic purposes. Its purpose is therapeutic.
No
The device description explicitly states it is manufactured from CP titanium or stainless steel and describes physical components like rods. This indicates a hardware device, not software only.
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 taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SYNERGY Spinal System is a surgical implant intended to stabilize the spine during fusion procedures. It is a physical device implanted into the body, not used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic tests performed on specimens.
Therefore, the SYNERGY Spinal System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SYNERGY Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system the SYNERGY Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.
In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the SYNERGY Spinal System are:
-
- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
-
- Idiopathic scoliosis.
-
- Kyphotic deformities of the spine.
-
- Paralytic scoliosis and/or pelvic obliquity.
-
- Lordotic deformities of the spine.
-
- Neuromuscular scoliosis associated with pelvic obliquity.
-
- Vertebral fracture or dislocation.
-
- Tumors.
-
- Spondylolisthesis.
-
- Stenosis.
-
- Pseudarthrosis.
-
- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the SYNERGY screws and lateral connectors are intended for sacral/iliac attachment only, and the SYNERGY hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.
The Bullet End Rods are intended for use with the Jackson Intrasacral Fixation Technique.
The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
Product codes
NKB, KWP, MNI, MNH
Device Description
The Polaris™ BE Rods are manufactured from CP titanium or stainless steel in a diameter of 6.35mm. Two styles of rods are available, double bullet-ended and single bullet-ended where the opposite end is blunt like standard rods. This tip design facilitates the use of an intrasacral surgical technique (Jackson Intrasacral Fixation Technique). Lengths vary from 6 to 60cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, thoracic, lumbar, sacral spine, L5-S1 vertebral joint, L3 to S1/Ilium, T1 to the Sacrum/Ilium, T10 to L3, T5 to L5
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)
Non-Clinical Testing: Because the Polaris™ BE Rods are identical in material, diameter and minimum and maximum length, they can be expected to perform mechanically in the same manner as the predicates. An engineering rationale is provided.
Clinical Testing: No clinical testing is necessary for a determination of substantial equivalence. However, a paper containing retrospective outcome data for intrasacral rod fixation is provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
K07/377
AUG -6 2007
Section 5: 510(k) Summary
-
Auqust 1, 2007 Preparation Date:
Applicant/Sponsor: Biomet Spine (formally EBI Spine) 100 Interpace Parkway Parsippany, NJ 07054 -
Contact Person: Debra Bing Director of Regulatory Affairs Biomet Spine
-
Polaris™ BE Rods Proprietary Name:
-
Common Name: Spinal Rods
-
Classification Name: Application, Fixation, Spinal Interlaminal (87 KWP) Orthosis, Spinal Pedicle Fixation (MNI) Orthosis, Spondylosthesis Spinal Fixation (MNH) Orthosis, Spinal Pedicle Fixation, for Degenerative Disc Disc Disease (NKB)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Synerqy™ Spinal System (Interpore Cross, Inc.*) K940631
Synerqy™ Ti Posterior Spinal System (Interpore Cross, Inc. * ) K950099
Device Description: The Polaris™ BE Rods are manufactured from CP titanium or stainless steel in a diameter of 6.35mm. Two styles of rods are available, double bullet-ended and single bullet-ended where the opposite end is blunt like standard rods. This tip design facilitates the use of an intrasacral surgical technique (Jackson Intrasacral Fixation Technique). Lengths vary from 6 to 60cm.
- Interpore Cross, Inc. is now a Biomet Company
1
Intended Use:
INDICATIONS-FOR-USE
The SYNERGY Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion.
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system the SYNERGY Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Ilium.
In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the SYNERGY Spinal System are:
-
- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
-
- Idiopathic scoliosis.
-
- Kyphotic deformities of the spine.
-
- Paralytic scoliosis and/or pelvic obliquity.
-
- Lordotic deformities of the spine.
-
- Neuromuscular scoliosis associated with pelvic obliquity.
-
- Vertebral fracture or dislocation.
-
- Tumors.
2
-
- Spondylolisthesis.
-
- Stenosis.
-
- Pseudarthrosis.
-
- Unsuccessful previous attempts at spinal fusion.
For posterior, non-pedicle, screw use, the SYNERGY screws and lateral connectors are intended for sacral/iliac attachment only, and the SYNERGY hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Ilium.
The Bullet End Rods are intended for use with the Jackson Intrasacral Fixation Technique.
The Adjustable Length Rod is intended for in situ adjustment after placement of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
Summary of Technologies: The technological characteristics (materials, design, sizing, indications) of the Polaris™ BE Rods are similar to or identical to the predicate devices.
Non-Clinical Testing: Because the Polaris™ BE Rods are identical in material, diameter and minimum and maximum length, they can be expected to perform mechanically in the same manner as the predicates. An engineering rationale is provided.
Clinical Testing: No clinical testing is necessary for a determination of substantial equivalence. However, a paper containing retrospective outcome data for intrasacral rod fixation is provided.
All trademarks are property of Biomet, Inc.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG -6 2007
Biomet Spine (Former EBI Spine) % Ms. Debra Bing Director of Regulatory Affairs 100 Interpace Parkway Parsippany, NJ 07054
Re: K071377
Trade/Device Name: Polaris™ BE Rods Regulation Number; 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWP, MNI, MNH Dated: May 16, 2007 Received: May 17, 2007
Dear: Ms. Debra Bing:
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. Ilisting 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.
4
Page 2 - Ms. Debra Bing
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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K071377
Device Name: Polaris™ BE Rods
INDICATIONS-FOR-USE
The SYNERGY Spinal System implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion,
The implants are attached to the spine posteriorly by means of hooks and/or screws joined with rods and anteriorly by means of vertebral screws joined with rods.
As a pedicle screw system the SYNERGY Spinal System is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. The levels of screw fixation are L3 to S1/Illium.
In addition, the pedicle screw system may also be used to provide immobilization and stabilization of spinal segments, in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a posterior, non-pedicle, screw and hook system, and an anterolateral, intervertebral body screw system, the specific indications for the SYNERGY Spinal System are:
-
- Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Idiopathic scoliosis. 2.
-
- Kyphotic deformities of the spine.
-
- Paralytic scoliosis and/or pelvic obliquity.
-
- Lordotic deformities of the spine.
- Neuromuscular scoliosis associated with pelvic obliquity. ଚି.
-
- Vertebral fracture or dislocation.
-
- Tumors.
-
- Spondylolisthesis.
-
- Stenosis.
-
- Pseudarthrosis.
-
- Unsuccessful previous attempts at spinal fusion.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X |
---|---|
------------------------------------------------- | --- |
AND/OR
| Over-The-Counter Use
(21 CFR 807 Subpart C) | NO |
---|---|
------------------------------------------------ | ---- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milliron
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
Page 1 of 2
6
K071377 Indications for Use (continued)
For posterior, non-pedicle, screw use, the SYNERGY screws and lateral connectors are intended for sacral/iliac attachment only, and the SYNERGY hooks and transverse connectors are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use are T1 to the Sacrum/Illium.
The Bullet End Rods are intended for use with the Jackson Intrasacral Fixation Technique.
The Adjustable Length Rod is intended for in situ adjustment of the hooks or screws during spinal fusion surgery.
For anterior use, the recommended levels of attachment are: T10 to L3 for the double rod constructs and T5 to L5 for the single rod constructs. The 4.75 mm diameter rod system can be used in single and double rod constructs while the 6.35 mm diameter rod system is to only be used in single rod constructs. In all cases, instrumentation must be at least 1 cm from any major vessel.
Prescription Use _ × AND/OR Over-The-Counter Use _ NO (Part 21 CFR 801 Subpart D) (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)
Mark N. Wilkerson
510(k) Number_