(17 days)
No
The summary describes a mechanical spinal fixation system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests.
No
The device is described as a spinal fixation system, intended to provide immobilization and support as an adjunct to fusion, rather than actively treating or curing a condition.
No
The device is a spinal system intended for posterior, non-cervical fixation and immobilization of spinal segments, acting as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a "thoracolumbosacral pedicle screw system containing metallic implants" and lists various hardware components like screws, hooks, and rods. This indicates it is a physical 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The LineSider™ Spinal System is described as a system of metallic implants (screws, hooks, rods, etc.) intended for surgical implantation to provide immobilization of spinal segments.
- Intended Use: The intended use clearly states it's for posterior, non-cervical fixation in skeletally mature and pediatric patients as an adjunct to fusion for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used in vivo (within the body), not a diagnostic test performed in vitro (outside the body).
N/A
Intended Use / Indications for Use
LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider™ Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, LineSider™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP
Device Description
The LineSider™ Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. The LineSider™ Spinal System subject to this 510(k) adds non-modular screws to the line offered under K190360.
The purpose of this submission is to expand the LineSider™ Spinal System to include nonmodular screws to the line of previously cleared screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical
Indicated Patient Age Range
skeletally mature patients, pediatric 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)
In support of this Special 510(k) Device Modification Premarket Notification, Integrity Implants has conducted confirmatory mechanical testing to demonstrate that the modifications to the LineSider™ Spinal System provide adequate and substantially equivalent mechanical strength for their intended use. The testing that was completed was dynamic compression bending per ASTM F1717.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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December 3. 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Integrity Implants Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K203367
Trade/Device Name: LineSider™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: November 13, 2020 Received: November 16, 2020
Dear Nathan Wright:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
510(k) Number (if known)
K203367
Device Name LineSider™ Spinal System
Indications for Use (Describe)
LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pediation in pediatric patients, LineSider™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis) including idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. Additionally, LineSider™ is intended to treat pediatric patients diagnosed with the following conditions: spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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FORM FDA 3881 (7/17)
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510(K) SUMMARY
| Submitter's Name: | Integrity Implants Inc. |
|---|---|
| Submitter's Address: | 354 Hiatt Drive |
| Palm Beach Gardens, FL 33418 | |
| Submitter's Telephone: | 561-529-3861 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | November 13, 2020 |
| Trade or Proprietary Name: | LineSider™ Spinal System |
| Common or Usual Name: | Thoracolumbosacral Pedicle Screw System |
| Classification: | Class II per 21 CFR §888.3070 and per 21 CFR §888.3050 |
| Product Code: | NKB, KWP |
| Classification Panel: | Orthopedic and Rehabilitation Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The LineSider™ Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy. The LineSider™ Spinal System subject to this 510(k) adds non-modular screws to the line offered under K190360.
The purpose of this submission is to expand the LineSider™ Spinal System to include nonmodular screws to the line of previously cleared screws.
Indications for Use
LineSider™ Spinal System, with or without MIS instrumentation, is intended for posterior, noncervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider™ Spinal System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, LineSider™ Spinal System is intended to treat
4
pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider™ Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The indications for use for the subject LineSider™ Spinal System are identical to the indications of the previously cleared LineSider™ Spinal System (K190360).
TECHNICAL CHARACTERISTICS
The LineSider™ Spinal System implants are made from Ti-6A1-4V ELI conforming to ASTM F136, commercially pure titanium conforming to ASTM F67, and Co28-Cr6-Mo conforming to ASTM F1537. The subject system expands the LineSider™ Spinal System screws to include nonmodular screws. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use
- Technological Characteristics
- Materials of manufacture ●
- Sizes
| 510k Number | Trade or Proprietary or Model
Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|-----------------------------|-------------------|
| K190360 | LineSiderTM Pedicle Screw System | Integrity Implants
Inc. | Primary |
| K171170 | M.U.S.T. Pedicle Screw System | Medacta
International SA | Additional |
PERFORMANCE TESTING SUMMARY
In support of this Special 510(k) Device Modification Premarket Notification, Integrity Implants has conducted confirmatory mechanical testing to demonstrate that the modifications to the LineSider™ Spinal System provide adequate and substantially equivalent mechanical strength for their intended use. The testing that was completed was dynamic compression bending per ASTM F1717.
CONCLUSION
The subject LineSider™ Spinal System is very similar to the previously cleared LineSider™ Spinal System and the additional predicate. The subject LineSider™ Spinal System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The
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overall technology characteristics and mechanical performance data lead to the conclusion that the LineSider™ Spinal System is substantially equivalent to the predicate devices.