CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM
Device Facts
| Record ID | K221646 |
|---|---|
| Device Name | CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product Code | NKB · Orthopedic |
| Decision Date | Oct 4, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3070 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
CD Horizon™ Astute™ Spinal System The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
Device Story
Spinal fixation systems (rods, screws, hooks, connectors, plates) provide posterior/anterolateral stabilization for spinal fusion or deformity correction. Surgeons implant components to rigidly lock spinal segments. Fenestrated screws allow PMMA bone cement injection for augmented fixation in patients with advanced tumors. Growth rod systems allow periodic lengthening surgeries in children until skeletal maturity. Systems are used in OR by orthopedic/neurosurgeons. Output is mechanical stabilization of the spine; aids fusion or maintains deformity correction. Benefits include pain reduction, spinal column integrity restoration, and deformity management.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing performed in accordance with FDA guidance for passive implants in the MR environment, specifically ASTM F2052 (displacement force), ASTM F2213 (torque), ASTM F2119 (image artifacts), and ASTM F2182 (RF heating).
Technological Characteristics
Materials: Medical grade titanium alloy, stainless steel (ASTM F138/ISO 5832-1/9), cobalt-chromium-molybdenum alloy, PEEK Optima-LT1, tantalum. Components: Rods, screws (cannulated/fenestrated), hooks, connectors, plates, crosslinks. Energy: Passive mechanical fixation. Sterilization: Non-sterile (provided for sterilization by user). Connectivity: None. Software: None.
Indications for Use
Indicated for patients with degenerative disc disease (DDD), spondylolisthesis, retrolisthesis, trauma (fracture/dislocation), spinal stenosis, scoliosis, kyphosis, lordosis, tumor, pseudarthrosis, or failed fusion. Specific systems indicated for pediatric patients <10 years with progressive, life-threatening early-onset spinal deformities/thoracic insufficiency. Contraindicated for use with incompatible metal alloys (e.g., stainless steel with titanium) in the same construct.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- CD Horizon™ Spinal System (K201407)
- CD HORIZON™ ASTUTE™ SPINAL SYSTEM (K191066)
- CD HORIZON Growth Rod Conversion Set (K150200)
- CD Horizon™ Fenestrated Screw Set (K201362)
- COLORADO 2™ SPINAL SYSTEM (K030875)
- TITANIUM GDLH POSTERIOR SPINAL SYSTEM (K954645)
- SHILLA GROWTH GUIDANCE SYSTEM (K140750)
- TENOR™ SPINAL SYSTEM (K022191)
Related Devices
- K122145 — LANX SPINAL FIXATION SYSTEM · Lanx, Inc. · Aug 17, 2012
- K193100 — RESPONSE Spine System, RESPONSE 4.5/5.0 Spine System, RESPONSE 5.5/6.0 Spine System · OrthoPediatrics Corp. · Mar 24, 2020
- K031888 — MODIFICATION TO CD HORIZON SPINAL SYSTEM · Medtronic Sofamor Danek · Jun 27, 2003
- K980184 — CD SPINAL SYSTEM · Sofamor Danek USA,Inc. · Dec 18, 1998
- K123487 — GSO GS1 CANNULATED SCREW SYSTEM · Gold Standard Orthopaedics, LLC · Mar 11, 2013
Submission Summary (Full Text)
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October 4, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Medtronic Sofamor Danek USA, Inc. Shana Foster Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
## Re: K221646
Trade/Device Name: CD HORIZON™ ASTUTE™ SPINAL SYSTEM: CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™ SPINAL SYSTEM; CD Horizon™ Fenestrated Screw Set; COLORADO 2™ SPINAL System; GDLHTM POSTERIOR SPINAL SYSTEM; SHILLA™ Growth Guidance System; TENOR™ SPINAL SYSTEM Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWQ, KWP, NQP, PGM Dated: September 6, 2022 Received: September 12, 2022
Dear Shana Foster:
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.
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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 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.
for
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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510(k) Number (if known) K221646
Device Name CD HORIZON™ ASTUTE™ Spinal System
#### Indications for Use (Describe)
CD Horizon™ Astute™ Spinal System
The CD Horizon™ Astute™ Spinal System is intended to provide for posterior, supplemental fixation when used with an interbody fusion cage for patients diagnosed with degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"> <b> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> | <span style="white-space: nowrap;"> <b> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </b> </span> |
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{3}------------------------------------------------
#### 510(k) Number (if known)
#### K221646
#### Device Name CD Horizon™ Fenestrated Screw Set
#### Indications for Use (Describe)
CD Horizon™ Fenestrated Screws
When used without cement, CD Horizon™ Fenestrated Screws (with or without Sextant™ or Longitude™ instrumentation) are intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD- defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tumor and/or trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis), pseudarthrosis, and/or failed previous fusion.
Additionally, CD Horizon™ Fenestrated Screws may be used for immobilization when used for trauma (e.g. fracture or dislocation) with the usage of bone graft material left to the surgeon's discretion.
When used in conjunction with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic, lumbar, or sacral spine in whom life
expectancy is of insufficient duration to permit achievement of fusion™ Fenestrated Screws augmented with Medtronic HV-R™ Fenestrated Screw Cement or Kyphon™ Xpede™ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{4}------------------------------------------------
510(k) Number (if known) K221646
Device Name CD HORIZON™ Growth Rod Conversion Set
#### Indications for Use (Describe)
CD Horizon™ Growth Rod Conversion Set
The CD Horizon™ Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set may be used with any cleared traditional CD Horizon™ Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD Horizon™ Growth Rod Conversion Set may not be used with PEEK rods, Spire™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{5}------------------------------------------------
510(k) Number (if known) K221646
Device Name CD HORIZON™ Spinal System
### Indications for Use (Describe)
CD Horizon™ Spinal System
The CD Horizon™ Spinal System with or without Sextant™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, CD Horizon™ Legacy™ 3.5mm rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedictic patients, CD Horizon™ Spinal System titanium, cobalt chrome, and stainless steel implants are indicated as an adjunct to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, and congenital scoliosis, Additionally, the CD Horizon™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD Horizon™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (12 - S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
The CD Horizon™ Spire™ plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
To achieve additional levels of fixation, CD Horizon™ Spinal System rods may be connected to the Vertex™ Reconstruction System with the Vertex™ rod connector. Refer to the Vertex™ Reconstruction System package insert for a list of the Vertex™ indications of use.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
{6}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
{7}------------------------------------------------
510(k) Number (if known) K221646
Device Name GDLH™ Posterior Spinal System
### Indications for Use (Describe)
GDLH™ Posterior Spinal System
The GDLH™ Posterior Spinal System, when using TSRH™ variable angle screws, is intended only for patients (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed or attached to the lumbar and sacral spine: and (d) having the device removed after the development of a solid fusion mass.
When properly used. this system is intended to assist stabilization until a solid spinal fusion develops. Except for situations where screws are attached to the lumbar and sacral spine via a posterior surgical approach in a GDLH™ construct for the treatment of severe spondylolisthesis (Grade 4) at the L5-S1 vertebral joint, the specific indications for the GDLH™ Posterior Spinal System are the following:
· Degenerative disc disease (DDD - as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule).
- Pseudoarthrosis.
- · Stenosis.
- · Spondylolisthesis.
- · Spinal deformities such as scoliosis, kyphosis, and lordosis.
- · Fracture.
- · Unsuccessful previous attempts at spinal fusion.
- · Tumor resection.
Nota bene: the GDLH™ Posterior Spinal System is limited to non-cervical use. TSRH™ variable angle with the GDLH™ Posterior Spinal System, are intended for sacral/iliac attachment only. GDLH™ hooks and Crosslink™ bars are intended for posterior thoracic and/or lumbar use only.
Type of Use (Select one or both, as applicable)
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{8}------------------------------------------------
510(k) Number (if known)
#### K221646
Device Name COLORADO 2™ Spinal System
### Indications for Use (Describe)
Colorado 2TM Spinal System
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the Colorado 2™ Spinal System is indicated for one or more of the following: ( ) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (5) kyphosis, (6) spinal tumor, and/or (7) pseudarthrosis.
In addition, when used as a pedicle screw fixation system, the Colorado 2™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5 S1) vertebral joint, (2) receiving fusions using autogenous bone graft only, (3) having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (4) having the device removed after the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the Colorado 2™ Spinal System is intended for the following indications: (1) degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e. scoliosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection. When used as an anterolateral thoracic/lumbar system, the Colorado 2™ Spinal System is intended for the following indications: (1) DDD (as defined by back pain of discogenic origin with degeneration of the disc confirmed b patient history and radiographic studies), (2) spinal stenosis, (3) spinal deformities (i.e. scoliosis, kyhosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, and/or (7) tumor resection.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{9}------------------------------------------------
510(k) Number (if known) K221646
Device Name SHILLATM Growth Guidance System
### Indications for Use (Describe)
Shilla™ Growth Guidance System
The Shilla™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset seculiosis, which are associated with or at risk of thoracic insufficiency syndrome. The Shilla™ Growth Guidance System is intended to be removed after skeletal maturity.
Type of Use (Select one or both, as applicable)
| [X] Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
{10}------------------------------------------------
510(k) Number (if known) K221646
Device Name TENOR™ Spinal System
## Indications for Use (Describe)
Tenor™ Spinal System
The Tenor™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (L5-S1) vertebral joint; (b) receiving fusions using autogenous bone graft only; (c) having the device fixed to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) having the device removed after the development of a solid fusion mass. Note: Tenor™ Plates are intended for the L5-S1 pedicle screw indication only.
The Tenor™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications:
• Degenerative disc disease (DDD - as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- · Pseudarthrosis.
- · Stenosis.
- · Spondylolisthesis.
- · Spinal deformities such as scoliosis, kyphosis, and/or lordosis.
- · Fracture.
- Tumor resection.
When used for posterior non-pedicle screw fixation. the Tenor™ Spinal System is intended for thoracic, lumbar, and sacral (T1- Sacrum) fixation only.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> <b>[X]</b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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## 510(k) SUMMARY MEDTRONIC Sofamor Danek MRI Update for Medtronic ThoracoLumboSacral Anterior & Posterior Spinal Fixation Systems October 4, 2022
| Submitter: | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: (901)396-3133<br>Fax: (901) 346-9738 |
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| Contact Person: | Shana Foster<br>Regulatory Affairs Specialist |
| Date Prepared: | October 4, 2022 |
| Name of Device: | Medtronic ThoracoLumboSacral Anterior &<br>Posterior Spinal Fixation Systems<br>1. CD HORIZON™ ASTUTE™ SPINAL<br>SYSTEM<br>2. CD HORIZON™ Growth Rod Conversion<br>Set<br>3. CD HORIZON™ SPINAL SYSTEM<br>4. CD Horizon™ Fenestrated Screw Set;<br>Applies to US only parts<br>5. COLORADO 2™ SPINAL System<br>6. GDLH™ POSTERIOR SPINAL<br>SYSTEM<br>7. SHILLA™ Growth Guidance System<br>8. TENOR™ SPINAL SYSTEM |
| Common Name (with<br>target population<br>intended for MRI<br>construct) | CD HORIZON™ ASTUTE™ SPINAL<br>SYSTEM: Rods & Set Screws <br><br>CD HORIZON™ Growth Rod Conversion Set:<br>Set Screws & Connectors <br><br>CD HORIZON™ SPINAL SYSTEM: Rods,<br>Staples, Screws, Set Screws, Bolts,<br>Connectors/Dominos, Hooks, Nut Caps, Plates,<br>Sliders, Washers, Staples, Crosslinks, Rod<br>Stoppers, Spacer, C-Rings, Nuts |
| | CD Horizon™ Fenestrated Screw Set: Screws |
| | COLORADO 2™ SPINAL System: Connectors,<br>Crosslinks, Screws, Set Screws, Plates, Clamps,<br>Dominos, Hooks, Nuts, Rods, Staples |
| | GDLH™ POSTERIOR SPINAL SYSTEM:<br>Connectors, Crosslinks, Rods, Hooks & Set<br>Screws |
| | SHILLA™ Growth Guidance System: Set<br>Screws, Screws, Rods & Crosslinks |
| | TENOR™ SPINAL SYSTEM: Clamps,<br>Connectors, Hooks, Crosslinks, Nuts, Rods &<br>Screws |
| Regulatory Class,<br>Regulation Number,<br>Regulation Name and<br>Device Product Code: | KWP, KWQ, NKB, NQP, PGM<br>1. 21 CFR 888.3050 Device Class II KWP -<br>Appliance, Fixation, Spinal Interlaminal<br>2. 21 CFR 888.3060 Device Class II KWQ -<br>Appliance, Fixation, Spinal Intervertebral Body)<br>3. 21 CFR 888.3070 Device Class II See indented<br>list below:<br>a. NKB - Thoracolumbosacral Pedicle Screw<br>System<br>b. NQP - Posterior Metal/Polymer Spinal<br>System, Fusion<br>c. PGM - Growing Rod System |
| Trade Name: | 1. CD HORIZON™ ASTUTE™ SPINAL<br>SYSTEM<br>2. CD HORIZON™ Growth Rod Conversion<br>Set<br>3. CD HORIZON™ SPINAL SYSTEM<br>4. CD Horizon™ Fenestrated Screw Set;<br>Applies to US only parts<br>5. COLORADO 2™ SPINAL System |
| | 6. GDLH™ POSTERIOR SPINAL<br>SYSTEM |
| | 7. SHILLA™ Growth Guidance System |
| | 8. TENOR™ SPINAL SYSTEM |
| Predicate Devices: | • Primary Predicate 1- K201407 CD Horizon™ Spinal<br>System (S.E. 09/10/2020) |
| | • Predicate 2- K191066 CD HORIZON™ ASTUTE™<br>SPINAL SYSTEM (S.E. 10/03/2019) |
| | • Predicate 3- K150200 CD HORIZON Growth Rod<br>Conversion Set (S.E. 02/25/2015) |
| | • Predicate 4- K201362 CD Horizon™ Fenestrated<br>Screw Set, CD Horizon™ Spinal System, Kyphon™<br>HV-R™ Bone Cement (S.E. 08/19/2020) |
| | • Predicate 5- K030875 MODIFICATION TO<br>COLORADO 2SPINAL SYSTEM (S. E. 06/24/2003) |
| | • Predicate 6- K954645 TITANIUM GDLH<br>POSTERIOR SPINAL SYSTEM (S.E. 01/16/1996) |
| | • Predicate 7- K140750 SHILLA GROWTH<br>GUIDANCE SYSTEM (S.E. 07/17/2014) |
| | • Predicate 8- K022191 MODIFICATION TO TENOR<br>SPINAL SYSTEM (S.E. 08/28/2002) |
| Description of Devices: | CD HORIZON™ ASTUTE™ SPINAL<br>SYSTEM |
| | The CD Horizon™ Astute™ Spinal System consists of a<br>variety of sizes of rods, as well as set screws, which are<br>used with bone screws from the CD Horizon™ Solera™<br>Spinal System, to create a variety of rigidly locked<br>configurations, with each construct being tailored to the<br>individual case. |
| | CD Horizon™ Astute™ Spinal System implant<br>components are fabricated from medical grade titanium<br>alloy, tantalum, or polyetheretherketone (PEEK). |
| | Medical grade titanium, titanium alloy, or medical grade<br>cobalt-chromium-molybdenum alloy may be used<br>together. Never use titanium, titanium alloy, or medical<br>grade cobalt-chromium-molybdenum alloy with stainless |
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PEEK implants may be used with titanium alloy or cobaltchromium-molybdenum alloy implants. CD Horizon™ Astute™ Spinal System rods are not to be used with Crosslink™M plates, fixed angle screws, sagittally adjusting screws, or in pediatric patients. To achieve best results, do not use CD Horizon™ Astute™ Spinal System implant components with components from any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. CD HORIZON™ Growth Rod Conversion Set The CD Horizon™ Growth Rod Conversion Set consists of a variety of inline connectors used with certain CD Horizon™ Spinal System components to create posterior pedicle screw and hook constructs intended for treatment of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD Horizon™ Growth Rod Conversion Set is used with CD Horizon™ Spinal System rods (ranging in diameter from 3.5mm to 5.5mm), pedicle screws, hooks, and connectors of various sizes. These implants are used to form a distinct spinal construct in growing children to correct spinal deformities in a non-fusion manner. Similar to CD Horizon™ implants used in fusion cases, these components are rigidly locked into a variety of configurations with each construct being tailor-made for the individual. As the patient grows, subsequent lengthening surgeries are performed periodically to reapply tension/distraction to the construct. These surgeries are repeated until the child has reached skeletal maturity, at which point the implants may be removed. Certain components within the CD Horizon™ Spinal System are excluded for use in pediatric patients and, therefore, are excluded for use with the CD Horizon™ Growth Rod Conversion Set. These include PEEK rods, Shape Memory Alloy Staples and Spire™ Plates. All
steel in the same construct. Only use set screws designed
for use with CD Horizon™ Astute™ rods.
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| screws used in pediatric cases are only cleared for use via<br>a posterior approach.<br>CD Horizon™ Growth Rod Conversion Set components<br>are fabricated from medical grade stainless steel or<br>titanium alloy. Compatible CD Horizon™ Spinal System<br>implant components are fabricated from medical grade<br>stainless steel, medical grade titanium, titanium alloy,<br>and/or medical grade cobalt-chromium-molybdenum<br>alloy.<br>Medical grade titanium, titanium alloy, and/or medical<br>grade cobalt-chromium-molybdenum alloy may be used<br>together. Never use titanium, titanium alloy, and/or<br>medical grade cobalt-chromium-molybdenum alloy with<br>stainless steel in the same construct.<br>To achieve best results, do not use any of the CD<br>Horizon™ Growth Rod Conversion Set implant<br>components with components from any other system or<br>manufacturer unless specifically allowed to do so in this<br>or another Medtronic document. |
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| CD HORIZON™ SPINAL SYSTEM |
| The CD Horizon™ Spinal System consists of a variety of<br>shapes and sizes of rods, hooks, screws, Crosslink™<br>Plates, staples, and connecting components, as well as<br>implant components from other Medtronic spinal systems<br>which can be rigidly locked into a variety of<br>configurations, with each construct being tailor-made for<br>the individual case.<br>A subset of CD Horizon™ Spinal System components<br>may be used for posterior pedicle screw fixation in<br>pediatric cases. These constructs may be comprised of a<br>variety of shapes and sizes of rods (ranging in diameter<br>from 3.5mm to 6.35mm), hooks, screws, Crosslink™<br>plates, and connecting components. Similar to the CD<br>Horizon™ implants used in adult cases, these components<br>can be rigidly locked into a variety of configurations, with<br>each construct being tailor-made for the individual case.<br>Certain components within the CD Horizon™ Spinal<br>System are specifically excluded for use in pediatric<br>patients. These include PEEK rods, Spire™ plates. Screws<br>used in pediatric cases are only cleared for use via a |
| posterior approach. All components used in pediatric |
| cases are fabricated from medical grade stainless steel, |
| medical grade titanium, titanium alloy, and medical grade |
| cobalt-chromium-molybdenum alloy. |
| Certain implant components from other Medtronic spinal |
| systems can be used with the CD Horizon™ Spinal |
| System in non- pediatric cases. These components include |
| TSRH™ rods, hooks, screws, plates; Crosslink™ plates, |
| connectors, staples and washers; GDLH™ rods, hooks, |
| connectors; Crosslink™ bar and connectors and |
| Medtronic multi-axial rods and screws. Note that certain |
| components are specifically designed to connect to |
| specific rod diameters, while other components can |
| connect to multiple rod diameters. Care should be taken |
| so the correct components are used in the spinal construct. |
| CD Horizon™ hooks are intended for posterior use only. |
| CD Horizon™ staples and associated screws are intended |
| for anterior use only. However, for patients of smaller |
| stature and pediatric patients, CD Horizon™ 4.5mm rods |
| and associated components may be used posteriorly. |
| CD Horizon™ Spinal System implant components are |
| fabricated from medical grade stainless steel, medical |
| grade titanium, titanium alloy, medical grade cobalt- |
| chromium-molybdenum alloy, or medical grade PEEK |
| Optima-LT1. Certain CD Horizon™ Spinal System |
| components may be coated with hydroxyapatite. |
| Never use stainless steel and titanium implant components |
| in the same construct. |
| Medical grade titanium, titanium alloy, and/or medical…
