(139 days)
No
The 510(k) summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to promote fusion for various spinal conditions, indicating a therapeutic purpose.
No
The device is a spinal fixation system, intended to promote fusion as an adjunct to treatment for various spinal conditions, not to diagnose them.
No
The device description explicitly states it is a "Spinal System" with "implant components" fabricated from "medical grade titanium alloy," indicating it is a hardware device, not software only.
No, 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 about a person's health.
- Device Description and Intended Use: The provided text clearly describes a spinal fixation device intended for surgical implantation to stabilize the spine and promote fusion. It is a physical implant used in the body, not a device used to test samples from the body.
The information provided about the device's materials, intended use (treating conditions like degenerative disc disease, trauma, deformities), and anatomical site (non-cervical spinal) all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Coral TM Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
NKB, MNH, MNI, KWP, KWQ
Device Description
The purpose of this submission is for additional sizes and designs of polyaxial screws for the Coral TM Spinal System. The Coral TM Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies. The Coral TM Spinal System implant components are fabricated from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spinal
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Theken Surgical Coral TM Spinal System, K041592
Reference Device(s)
Sofamor Danek Colorado II Spinal System, K991031, DePuy-Motech Moss Miami Spinal System, K955348, Ulrich GmbH tangoRS Polyaxial System, K052385
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.
0
K070962
AUG 2 2 2007
| A. Submitter Information | |
|---|---|
| Submitter's Name: | Theken Spine, LLC |
| Address: | 283 E. Waterloo |
| Akron, Ohio 44319 | |
| Telephone Number: | 330-773-7677 x221 |
| Fax Number: | 330-773-7697 |
| Contact Person: | Dale Davison |
| Date Prepared: | 8/20/07 |
| B. Device Information | |
| Trade Name: | Coral TM Spinal System |
| Common Name: | Pedicle Screw Spinal System |
| Classification: | MNI 888.3070 - Pedicle Screw Spinal System |
| MNH 888.3070 - Pedicle Screw Spinal System | |
| KWQ 888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
| KWP 888.3050 - Spinal Interlaminal Fixation Orthosis | |
| NKB 888.3060 – Spondylolisthesis Spinal Fixation System | |
| Predicate Device: | Theken Surgical Coral TM Spinal System, K041592 |
| Comparative Devices: | Sofamor Danek Colorado II Spinal System, K991031 (et al) |
| DePuy-Motech Moss Miami Spinal System, K955348 (et al) | |
| Ulrich GmbH tangoRS Polyaxial System, K052385 | |
| Device Description: | The purpose of this submission is for additional sizes and designs |
| of polyaxial screws for the Coral TM Spinal System. The Coral TM | |
| Spinal System components can be rigidly locked together in a | |
| variety of configurations to promote fusion for a wide variety of | |
| patient anatomies. The Coral TM Spinal System implant | |
| components are fabricated from medical grade titanium alloy Ti | |
| 6Al-4V (ELI) per ASTM F-136. | |
| Intended Use: | The Coral TM Spinal System is a non-cervical spinal fixation device |
| intended for use as a posterior pedicle screw fixation system, a | |
| posterior non-pedicle screw fixation system, or as an anterolateral | |
| fixation system. Pedicle screw fixation is limited to skeletally | |
| mature patients. The device is indicated as an adjunct to fusion for | |
| the following indications: degenerative disc disease (defined as | |
| discogenic back pain with degeneration of the disc confirmed by | |
| history and radiographic studies), spondylolisthesis, trauma (i.e., | |
| fracture or dislocation), spinal stenosis, deformities or curvatures | |
| (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, | |
| and failed previous fusion. | |
| Material Composition: | Implant grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 |
| and ISO 5832-3. |
1
070962
page 2 of 2
C. Substantial Equivalence
Theken Spine believes sufficient evidence exists to reasonably conclude that the additional components are substantially equivalent to the predicate device Coral™ Spinal System (K041592 SE 9/04), manufactured Substantially Cquiratent to the predicate device concept, the use of established, known materials, by Therefitsons, mechanical testing, indications for use, pre-production quality assurance planning and reatine configations, mechanies are used to treat the same conditions, possess the same precautions and contraindications for use, and equivalent potential for complications for the risk of use.
The subject device similarities include:
- The same indications for use ●
- ♥ The same operating principle
- . The same materials
- Implanted using the same surgical techniques and equipment type .
- The same manufacturing environment ◆
- The same sterilization process .
- The same packaging configurations
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circle around the eagle. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2007
% Mr. Dale Davison 283 E Waterloo Rd. Akron, OH 44319
Theken Spine LLC
Re: K070962
Trade/Device Name: Coral™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: July 20, 2007 Received: July 23, 2007
Dear Mr. Dale Davison:
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. 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
3
Page 2 -- Mr. Dale Davison
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,
Hiram B. Conger
FOR Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ___K070962
The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of General, Restorative, and Neurological Devices
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510(k) Number K070962