(84 days)
PLUS Pivot Link Spinal System
Not Found
No
The 510(k) summary describes a mechanical spinal instrumentation system consisting of hooks, screws, rods, and connectors. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies described are mechanical tests.
Yes.
The device is intended to treat various spinal disorders and provide immobilization and stabilization of spinal segments, which are therapeutic functions.
No
Explanation: The device is described as a spinal instrumentation system (hooks, screws, rods, and connectors) used to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal pathologies. Its purpose is treatment, not diagnosis.
No
The device description explicitly states it consists of physical components like hooks, screws, rods, and connectors made from stainless steel and titanium alloys. This indicates it is a hardware-based medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device consists of "hooks, screws, rods, and connectors" that are "assembled in a variety of constructs" and "placed to treat a variety of spinal disorders." This describes a surgical implant used within the body.
- Intended Use: The intended use describes the conditions the device is used to treat within the spine (degenerative disc disease, spondylolisthesis, fracture, etc.). This is a therapeutic use, not a diagnostic test performed on a sample.
The device is a spinal instrumentation system, which is a type of surgical implant.
N/A
Intended Use / Indications for Use
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history and radiographic studies)
- spondylolisthesis ●
- fracture ●
- spinal stenosis
- deformities (i.e. scoliosis, kyphosis, lordosis)
- . tumors
- failed previous fusion (pseudoarthrosis) .
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
- have the device removed after the development of a solid fusion. .
In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended 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 .
- failed previous fusion (pseudoarthrosis) .
Product codes (comma separated list FDA assigned to the subject device)
87 KWP, MNH, MNI
Device Description
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
noncervical spine, L5-S1 vertebra, L3 to sacrum, thoracic, lumbar, and sacral spine
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)
Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.
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.
PLUS Pivot Link Spinal System
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.
Not Found
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
§ 888.3050 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
AUG 0 1 2002
Image /page/0/Picture/2 description: The image shows the logo for SpineVision. The logo consists of a stylized black icon above the word "SpineVision" in a sans-serif font. Below the company name is the tagline "Spine systems for specialists" in a smaller font. The logo is simple and modern, and the tagline suggests that the company specializes in spine-related medical devices or services.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | SpineVision, Inc.
3003 Summit Blvd., Suite 1500
Atlanta, GA 30319
Phone: 404-460-5077 |
|--------------------------------------|------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Lynnette Whitaker
Vice President, Regulatory Affairs
574-269-3701 |
| TRADE NAME: | PLUS™ Pivot Link Universal System |
| COMMON NAME: | Rod, Hook, and Screw Spinal Instrumentation |
| CLASSIFICATION: | 888.3050 Spinal Interlaminal Fixation Orthosis
888.3070 Pedicle Screw Spinal System |
| DEVICE PRODUCT CODE: | Product code: 87 KWP, MNH, MNI |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | PLUS Pivot Link Spinal System, SpineVision, Inc. |
DEVICE DESCRIPTION AND INTENDED USE:
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
:00004
1
INDICATIONS FOR USE
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history and radiographic studies)
- spondylolisthesis ●
- fracture ●
- spinal stenosis
- deformities (i.e. scoliosis, kyphosis, lordosis)
- . tumors
- failed previous fusion (pseudoarthrosis) .
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
- have the device removed after the development of a solid fusion. .
In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended 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 .
- failed previous fusion (pseudoarthrosis) .
BASIS OF SUBSTANTIAL EQUIVALENCE:
The components of the PLUS Pivot Link Universal System are identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA for posterior spinal use. Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". Inside the circle is a stylized image of three human profiles facing to the right, with lines extending above them to create a sense of upward movement or flight. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 01 2002
Ms. Lynnette Whitaker Vice President, Regulatory Affairs SpineVision, Incorporated 3003 Summit Boulevard, Suite 1500 Atlanta, Georgia 30319
Re: K021507
Trade/Device Name: PLUSTM Pivot Link Universal System Regulation Number: 888.3050 and 888.3070 Regulation Name: Spinal Interlaminal Fixation Orthosis, Pedicle Screw Spinal System and Spondylolisthesis Spinal Fixation Device System Regulatory Class: II Product Code: KWP, MNI, and MNH Dated: May 8, 2002 Received: May 9, 2002
Dear Ms. Whitaker:
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.
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.
3
Page 2 -- Ms. Lynnette Whitaker
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Mark N. Mellem
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) ≤ ≥ ≤ ≤ ≤ ≤ ○ 7
PLUS™ Pivot Link Universal System, Additional Components Device Name:
Indications for Use:
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history . and radiographic studies)
- spondylolisthesis .
- fracture ●
- spinal stenosis .
- deformities (i.e. scoliosis, kyphosis, lordosis)
- tumors
- failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
- receive fusions using autogenous bone graft only; ●
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and .
- have the device removed after the development of a solid fusion. .
In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended 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
- failed previous fusion (pseudoarthrosis)
| Concurrence of CDRH. Office of Device Evaluation |
|---|
| -------------------------------------------------- |
Mark N. Milliken
Division Sign-Off Division of General. Restorative and Neurological Devices
510(k) Number K021507
Prescription Use
OR (Per 21 CFR 801.109) Over-The Counter Use