← Product Code [NKB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB) · K233951 # CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (K233951) _Medtronic Sofamor Danek USA, Inc. · NKB · Mar 27, 2024 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K233951 ## Device Facts - **Applicant:** Medtronic Sofamor Danek USA, Inc. - **Product Code:** [NKB](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB.md) - **Decision Date:** Mar 27, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3070 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic, Pediatric ## Intended Use 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), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™M 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 indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatic indications noted. When used for posterior non-cervical pedicle screw fixation in pediatric patients. CD Horizon™ Spinal System titanium. cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by turnor 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 spondylolisthess 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. Devices are 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, 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 Vertex™ indications. ## Device Story CD Horizon ModuLeX Spinal System comprises rods, hooks, screws, Crosslink plates, and connectors; used for posterior spinal fixation as adjunct to fusion. Components rigidly locked into patient-specific constructs. Used in clinical settings by surgeons. Provides mechanical stabilization of spinal segments to facilitate fusion. Benefits include correction of deformities and stabilization of unstable spinal segments. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included static compression, static torsion, compression fatigue (ASTM F1717), axial grip, axial torsion, flexion-extension static/fatigue (ASTM F1798), and MRI compatibility evaluation (ASTM F2503). ## Technological Characteristics Materials: medical grade stainless steel, titanium, titanium alloy, cobalt-chromium-molybdenum alloy, and PEEK Optima-LT1. Some components hydroxyapatite coated. Mechanical fixation via rods, screws, hooks, and plates. Standards: ASTM F1717, F1798, F2503. Non-powered, mechanical implant system. ## Regulatory 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 ([K221244](/device/K221244.md)) - CD Horizon Spinal System ([K153442](/device/K153442.md)) - CD Horizon Spinal System ([K210637](/device/K210637.md)) - CD Horizon Spinal System ([K223494](/device/K223494.md)) ## Reference Devices - Vertex Reconstruction System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ March 27, 2024 Image /page/0/Picture/1 description: The image shows the logo of 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The words "U.S. FOOD & DRUG" are on the first line, and "ADMINISTRATION" is on the second line. Medtronic Sofamor Danek USA, Inc. Justin O'Connor Pr. Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132 Re: K233951 Trade/Device Name: CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: February 9, 2024 Received: February 9, 2024 Dear Justin O'Connor: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Image /page/1/Picture/6 description: The image contains the name "Colin O'neill -S" in black font on the left side of the image. On the right side of the image is a light blue logo that appears to be "FDA". The text is arranged in two lines, with "Colin" on the first line and "O'neill -S" on the second line. The image appears to be a name and logo. 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K233951 #### Device Name CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) #### Indications for Use (Describe) 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), tumor, pseudarthrosis, and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD Horizon™M 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 indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatic indications noted. When used for posterior non-cervical pedicle screw fixation in pediatric patients. CD Horizon™ Spinal System titanium. cobalt chrome, and stainless steel implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD Horizon™ System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis, fracture caused by turnor 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 spondylolisthess 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. Devices are 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, 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 Vertex™ indications. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(k) Summary # MEDTRONIC CD HORIZON™ Spinal System # February 09, 2024 | I. Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133 | |-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Justin O'Connor
Pr. Regulatory Affairs Specialist
Telephone Number: (901) 396-3133
Email: justin.oconnor(@medtronic.com | | Date Prepared | February 09, 2024 | | II. Name of Device | CD Horizon™ ModuLeXTM Spinal System (Shanks, Head
Assemblies, and Set Screw) | | Common Name | Bone Screw, Pedicle Screw | | Classification Name | Thoracolumbosacral Pedicle Screw System | | Classification | Class II | | Product Codes | NKB, KWP, KWQ (888.3070, 888.3060, 888.3050) | | III. Predicate Devices | Primary Predicate:
CD Horizon™ Spinal System (K221244, S.E. 05/25/2022)
Additional Predicates:
CD Horizon™ Spinal System (K153442, S.E. 02/18/2016)
CD Horizon™ Spinal System (K210637, S.E. 04/30/2021)
CD Horizon™ Spinal System (K223494, S.E. 01/23/2023)
The predicates have not been subject to a design related recall. | | IV. Description | CD Horizon™ Spinal System
The CD Horizon™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, Crosslink™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. A subset of CD Horizon™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5 to 6.35mm), hooks, screws, Crosslink™ plates and connecting components. Similar to the CD Horizon™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Certain components within the CD Horizon™ Spinal System are specifically excluded for use in pediatric patients. These include PEEK rods, Shape Memory Alloy Staples, Spire™ plates, and Dynalok™ bolts. Screws used in pediatric cases are only cleared for use via a posterior approach. 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, and Crosslink™ bar and connectors; Liberty™ rods and screws; Dynalok™ Plus and Dynalok Classic™ bolts along with rod/bolt connectors; and Medtronic multi-axial rods and screws. Note: 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 CD Horizon™ Eclipse™ rods 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- | | V. Indications for Use | molybdenum alloy, or medical grade PEEK Optima-LT1. Certain
CD Horizon™ Spinal System components may be coated with
hydroxyapatite.

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, kyphosis, or lordosis),
tumor, pseudarthrosis, and/or failed previous fusion. Except for
hooks, when used as an anterolateral thoracic/lumbar system, the
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
indications in skeletally mature patients as an adjunct to fusion. The
3.5mm rods may be used for the specific pediatric indications noted.
When used for posterior non-cervical pedicle screw fixation in
pediatric patients, CD Horizon™ Spinal System titanium, cobalt
chrome, and stainless-steel implants are indicated as an adjunct to
fusion to treat progressive spinal deformities (i.e. scoliosis,
kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular
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 and/or
allograft. 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 (L2 – S1) in skeletally mature patients. Devices
| | | 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, 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 Vertex™ indications. | | | The subject devices have the same intended use, indications for use,
materials, similar overall design, fundamental technology,
sterilization, and surgical technique as the following CD Horizon™
Spinal System predicates: | | VI. Comparison of
Technological
Characteristics with
the Predicate Devices | K221244 (S.E. 05/25/2022) K153442 (S.E. 02/18/2016) K210637 (S.E. 04/30/2021) K223494 (S.E. 01/23/2023) | | | The subject and predicate implants have the same function and
fundamental scientific technology. | | | In accordance with the Guidance for Industry and FDA Staff –
Spinal System 510(k)'s, Medtronic has evaluated the subject
devices to demonstrate substantial equivalence to the predicate
devices. | | VII. Performance Data | The subject devices have been tested or rationalized based on if
Medtronic believes that testing is not warranted for the subject
devices as they do not present a new worst case when compared to
the predicates. | | | Testing and/or Rationales were completed for the following: | | | ASTM F1717: Static Compression, Static Torsion,
Compression Fatigue ASTM F1798:Axial Grip, Axial Torsion, Flexion
Extension Static, Flexion Extension Fatigue Screw Reduction to Failure Testing | | | • ASTM F2503: MRI Compatibility Evaluation | | | For the tested subject devices, the pre-determined acceptance criteria was met for all tests. For subject devices that are rationalized, all existing predicate data previously provided in the predicate 510(k)s is still applicable. | | | Therefore, Medtronic believes the design verification testing demonstrated that the subject devices are substantially equivalent to the predicate devices. | | VIII. Conclusion | Based on the supporting evidence provided in this premarket notification, Medtronic believes the subject devices are substantially equivalent to the predicate devices. | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K233951](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/NKB/K233951) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com