The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. These implants may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.

Device Description

The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology consists of Additively Manufactured (AM) titanium spacers of various lengths, and heights to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The open geometry of the implants allows them to be packed with autograft bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology in intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The subject Adaptix™ Interbody System Fusion devices are available in a variety of lengths and heights for treatment in lumbar interbody fusion procedures. The subject device is designed with a large hollow region in the center to house autograft or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. The design incorporates "honeycomb windows" through the interbody device to permit bone growth through the implant. The new bone formation through the Interbody Device is intended to provide long-term structural support and fusion at the implanted disc space. The Interbody Device incorporates Titan Surface Technologies™ including a macro-rough surface on the superior and inferior surfaces of the device along with the entire device being treated with nanoLOCK™ Surface Technology (MMN™) to improve fixation to the adjacent bone. The nanoLOCK™ Surface Technology (MMN™) provides a microscopic roughened surface with nano-scale features.

The subject device is manufactured from Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI) powder in accordance with ASTM F3001: Standard specification for additive manufacturing titanium-6 aluminum-4 vanadium ELI (Extra Low Interstitial) with powder bed fusion.

AI/ML Overview

This 510(k) clearance letter is for the Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology, which is an intervertebral body fusion device. This type of device is a physical implant designed to facilitate spinal fusion in patients with Degenerative Disc Disease (DDD).

Crucially, this document describes a medical device (an implant), not a software or AI-driven diagnostic/therapeutic device.

Therefore, most of the requested information regarding acceptance criteria and study design for AI/software devices (such as sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models) is not applicable to this 510(k) submission.

The "performance data" section in this document refers to the data demonstrating the safety and effectiveness of the physical implant, which typically involves mechanical testing, biocompatibility testing, material characterization, and comparison to predicate devices, rather than clinical performance data from a diagnostic algorithm.

Here's how to interpret the provided document in the context of your request:

Key Takeaway from the Document:

The current 510(k) submission (K250669) is not for a new device design or new technology assessment, but rather to expand the indications for use of an already cleared physical implant (Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology, K201267) to include the use of bone void fillers as an additional graft option.

The core argument for clearance is substantial equivalence to existing predicate devices, arguing that the expanded use does not introduce new safety or effectiveness concerns, as bone void fillers are widely used and the primary predicate device is already cleared.

Given this understanding, here's an attempt to answer your questions based on the provided text, highlighting where the information is not applicable due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for this type of device and submission):
For an interbody fusion device, the acceptance criteria typically revolve around:

Biocompatibility: The material (Ti-6Al-4V ELI) must be biocompatible and safe for long-term implantation.
Mechanical Strength/Durability: Ability to withstand physiological loads, prevent subsidence, and maintain stability. This is typically demonstrated through static and fatigue testing.
Pore Size/Osteoconductivity: The design (e.g., "honeycomb windows," macro-rough and nanoLOCK™ surfaces) should facilitate bone ingrowth and fusion.
Substantial Equivalence: The device must be demonstrated to be as safe and effective as predicate devices. For this specific submission, the crucial acceptance criterion is that adding bone void fillers does not negatively impact the safety or effectiveness of the pre-existing device.

Reported Device Performance (as described in the 510(k) Summary):
The document explicitly states:
"The subject Adaptix™ Interbody System devices do not require any additional data to support their expanded use with bone void fillers to facilitate intervertebral body fusion. This submission does not contain any new or modified implants since the original 510(k) clearance (K201267, S.E. 08-26-2020)."

"The overall design and dimensions of the subject devices are within the established size range of the predicate devices, ensuring compatibility and consistency in performance."

"The inclusion of bone void fillers as an additional graft option does not introduce new safety or effectiveness concerns. Bone void fillers are widely used in spinal fusion procedures and have been demonstrated to be safe and effective promoting bone growth and fusion."

Therefore, the "performance" demonstrated for this specific submission is that the device, when used with bone void fillers, maintains its established safety and effectiveness profile, relying on the prior clearance of the device itself and the known safety/effectiveness of bone void fillers.

2. Sample size used for the test set and the data provenance

Not Applicable: This is a physical implant device seeking expanded indications based on substantial equivalence, not an AI/software device requiring a clinical test set from patient data. The "test set" would have referred to mechanical testing and material characterization, which are not detailed here beyond stating the device is made from Ti-6Al-4V ELI in accordance with ASTM F3001.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No "ground truth" in the AI/ML sense (e.g., labeling of medical images) is established for an implant device. Clinical efficacy is ultimately determined by fusion rates and patient outcomes in clinical trials, but this 510(k) relies on substantial equivalence and previous data.

4. Adjudication method for the test set

Not Applicable: No diagnostic interpretations requiring adjudication are involved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This refers to AI-assisted diagnostic studies, which are not relevant to this physical interbody fusion device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This refers to the performance of an AI algorithm, not relevant to this physical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable in the AI/ML sense. For a physical implant, "ground truth" relates to successful fusion (bone growth) and clinical outcomes (pain reduction, functional improvement). This is typically established through radiographic evidence (CT scans, X-rays to confirm fusion), clinical examinations, and patient-reported outcomes from clinical studies, often comparing to a control or predicate. However, in this specific 510(k), the "ground truth" for the expanded use with bone void fillers is the established safety and effectiveness of bone void fillers themselves, and the prior data supporting the device's original clearance.

8. The sample size for the training set

Not Applicable: No AI/ML training set is involved.

9. How the ground truth for the training set was established

Not Applicable: No AI/ML training set is involved.

Summary for this specific 510(k) (K250669):

The submission is for an expanded indication for use of an already cleared spinal interbody fusion device (Adaptix™ Interbody System). The "acceptance criteria" and "study" are implicitly tied to demonstrating that the addition of bone void fillers as a graft option does not compromise the device's established safety and effectiveness.

The "study" that proves the device meets the "acceptance criteria" for this specific submission is a demonstration of substantial equivalence by:

Asserting that no new or modified implants are introduced.
Confirming the overall design and dimensions are consistent with predicate devices.
Citing the widespread use and established safety/effectiveness of bone void fillers in spinal fusion.
Pointing out that the language for bone void fillers mirrors that of other cleared predicate devices.

This 510(k) is a regulatory update based on existing knowledge and established practices, rather than the presentation of novel clinical study data for a new device or an AI algorithm.

Summary

FDA 510(k) Clearance Letter - Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology

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April 22, 2025

Medtronic Sofamor Danek, USA Inc.
Alicia Goins
International Regulatory Affairs Specialist
1800 Pyramid Place
Memphis, Tennessee 38132

Re: K250669
Trade/Device Name: Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Regulation Number: 21 CFR 888.3080
Regulation Name: Intervertebral body fusion device
Regulatory Class: Class II
Product Code: MAX
Dated: February 26, 2025
Received: March 5, 2025

Dear Alicia Goins:

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"

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(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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

Sincerely,

Brent Showalter -S

Brent Showalter, Ph.D.
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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K250669

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K250669

Please provide the device trade name(s).

Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
(Interbody Fusion Device)

Please provide your Indications for Use below.

These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate or a bone void filler cleared for use in intervertebral body fusion to facilitate fusion. These implants may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.

Please select the types of uses (select one or both, as applicable).
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

Adaptix™ Interbody System with Titan nanoLOCK™ Surface Page 9 of 34

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K250669 - 510(k) SUMMARY

MEDTRONIC Sofamor Danek
February 5, 2025

Submitter	Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738
Contact Person	Alicia GoinsRegulatory Affairs SpecialistTelephone: (901) 399-2440 (Direct)
Alternate Contact	Michelle ObenauerSr. Regulatory Affairs DirectorTelephone: (901) 399-2117 (Direct)
Date Prepared	February 5, 2025
Name of Device	Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Common Name	Interbody Fusion Device
Classification Name	Intervertebral Body Fusion Device with bone graft (21 CFR 888.3080)
Regulatory Class	Class II
Product Code	MAX
Predicate Devices	Primary Predicate:Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (K201267, SE 08/26/2020)Additional Predicates:NuVasive Modulus® TLIF and ALIF (K203714, SE 12/23/2021)J&J Conduit EIT™ Cellular Titanium T/PLIF (K222276, SE 10/15/2022)

K250669 - 510(k) SUMMARY
Page 1 of 3

Page 6

Description of Device

Indications for Use

Comparison of Technological Characteristics with the Predicate Devices

Both the subject device and predicate devices are implants which are intended for use and indicated for intervertebral body fusions in skeletally mature patients. Each intervertebral body fusion device is intended for use in interbody fusions in the treatment of symptomatic degenerative disc diseases (DDD) in the lumbar spine.

K250669 - 510(k) SUMMARY
Page 2 of 3

Page 7

The predicate and subject devices are intervertebral body fusion devices that share similar shape, size ranges, internal graft chamber volume, and surgical insertion technique.

Differences among the devices include material (PEEK or titanium) and shape. The subject device was originally cleared for use with autograft bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The subject application provides information to support the use of the subject device with bone void fillers cleared for use in intervertebral body fusion to facilitate fusion.

Performance Data

The subject Adaptix™ Interbody System devices do not require any additional data to support their expanded use with bone void fillers to facilitate intervertebral body fusion. This submission does not contain any new or modified implants since the original 510(k) clearance (K201267, S.E. 08-26-2020). The overall design and dimensions of the subject devices are within the established size range of the predicate devices, ensuring compatibility and consistency in performance. Additionally, the intended use of the subject device remains unchanged from the primary predicate, which is to facilitate intervertebral body fusion.

The inclusion of bone void fillers as an additional graft option does not introduce new safety or effectiveness concerns. Bone void fillers are widely used in spinal fusion procedures and have been demonstrated to be safe and effective promoting bone growth and fusion. Additionally, the language permitting the use of bone void fillers mirrors the indications in the additional predicates which have been previously cleared by the FDA and are substantially equivalent to the subject device. Further, the bone void fillers maintain their own indications for use in intervertebral body fusion when used in conjunction with an interverterbral body fusion device, such as the predicate and subject device. The incorporation of bone void fillers as a graft option to when promoting fusion is consistent with established practices and indications and does not impact the safety or effectiveness profile of the subject devices.

Conclusion

Based on the information contained in this submission, Medtronic believes that the subject Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is substantially equivalent to the following predicates:

K201267, SE 08/26/2020
K203714, SE 12/23/2021
K222276, SE 10/15/2022

K250669 - 510(k) SUMMARY
Page 3 of 3

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.