(41 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and its components, with no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is described as a "spinal fixation device" used as an "adjunct to fusion" for various spinal conditions, indicating its role in treating these conditions.
No
The device is a spinal fixation system, intended to promote fusion and used as an adjunct to fusion for various spinal conditions, not for diagnosing them.
No
The device description clearly states it is a "spinal fixation device" and mentions "components" that are "rigidly locked together," indicating a physical hardware system. The submission is for the addition of "cobalt chrome rods," further confirming it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal fixation. This is a therapeutic device, not a diagnostic one.
- Device Description: The description focuses on the physical components of a spinal system (rods, screws) designed to be implanted in the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies mentioned are mechanical testing, which is relevant for the structural integrity of an implant, not for diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
NKB, MNI, MNH, KWP, KWQ
Device Description
The purpose of this submission is the addition of cobalt chrome rods to the Coral™ Spinal System. The Coral™ Spinal System components can be rigidly locked together in a variety of configurations to promote fusion for a wide variety of patient anatomies.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K041592, K070962, K081414, K080792, K070551
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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K091266. Page 1 of 2
510(k) Summary (21 CFR Part 807.92)
A. Submitter Information Submitter's Name: Address:
Telephone Number: Fax Number: Contact Person: Date Prepared:
B. Device Information
Trade Name: Common Name:
Classification:
Predicate Device:
Device Description:
Intended Use:
Material Composition:
Theken Spine, LLC 1800 Triplett Blvd Akron, Ohio 44306 330-475-8600 330-773-7697 Dale Davison 4/29/2009
Coral™ Spinal System Pedicle Screw Spinal System
MNI 888.3070 - Pedicle Screw Spinal System MNH 888.3070 - Pedicle Screw Spinal System KWO 888.3060 - Spinal Intervertebral Body Fixation Orthosis KWP 888.3050 - Spinal Interlaminal Fixation Orthosis NKB 888.3070 - Spondylolisthesis Spinal Fixation System
Theken Surgical Coral™ Spinal System, K041592 Theken Surgical Coral™ Spinal System, K070962 Theken Surgical Coral™ Spinal System, K081414 K2M Range Spinal System, K080792 Pioneer Surgical Quantum Spinal System, K070551
The purpose of this submission is the addition of cobalt chrome rods to the Coral™ Spinal System. The Coral™ 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™ 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.
Implant grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136, CP titanium per ASTM F-67 and CoCr Alloy per ASTM F-1537.
JUN 1 0 2009
1
K091266
Page 2 of 2
Substantial Equivalence ﺰ
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, K070962 SE 8/07, and K081414 SE 7/08), manufactured by Theken Spine, LLC. This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, preproduction quality assurance planning and engineering analysis. All implants 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 biocompatible materials t
- Implanted using the same surgical techniques and equipment type ◀
- The same manufacturing environment ◆
- The same sterilization process .
- The same packaging configurations .
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Theken Spine LLC % Mr. Dale Davison Vice President-Engineering 1800 Triplett Boulevard Akron, Ohio 44306
JUN 1 0 2009
Re: K091266
Trade/Device Name: Coral™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, & KWQ Dated: April 29, 2009 Received: May 13, 2009
Dear Mr. 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 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
3
Page 2-Mr. Dale Davison
practice requirements as set forth in the quality systems (OS) 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/ucm115809.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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Brehm
rk N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_ KO 9 | 2 لماما
The Coral™ Spinal System is a non-cervical spinal fixation device intended for use as a The Ooral - Victor of 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 confired 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.
AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sum Hei
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091266
Page 1 of 1
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