The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should be skeletally mature and have had six months of nonoperative treatment.

The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.

Device Description

The T-PAL Spacer System is an interbody fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following intervertebral discectomy. The T-PAL Applicator is used to insert the T-PAL Spacer into the disc space. The T-PAL Applicator is composed of an inner shaft and handle (outer shaft). The scope of this submission is to develop an additional T-PAL Applicator option for surgeons to facilitate insertion of the T-PAL Spacer and final positioning in the interbody disc space.

AI/ML Overview

Here's an analysis of the provided text regarding the DePuy Synthes T-PAL Spacer System, focusing on the acceptance criteria and study information:

Based on the provided text, the device in question is the T-PAL Advanced Applicator which is a minor modification to the already cleared T-PAL Applicator. This submission (K181231) is for the modified applicator, not the T-PAL Spacer System itself, though the applicator is used with the spacer system.

The submission is a 510(k) for substantial equivalence. This means the device is being compared to a legally marketed predicate device (T-PAL Spacer System K100089 and DePuy Synthes T-PAL Ti Spacer System K151276) to demonstrate that it is as safe and effective.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Performance acceptance criteria for mechanical testing	"The performance acceptance criteria was met."

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

Test Set Sample Size: Not explicitly stated. The text mentions "mechanical testing simulated the insertion of the implant," but does not provide details on the number of tests, specific loads, cycles, or other parameters of the mechanical testing.
Data Provenance: Not explicitly stated, but it is implied to be from internal lab testing conducted by the manufacturer, DePuy Synthes. There is no mention of country of origin for the data or whether it was retrospective or prospective. Given it's a 510(k) for a modified component, it's highly likely to be internal, prospective, laboratory-based testing.

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

This information is not applicable and not provided in the document. The study described is mechanical testing, not a clinical study involving human assessment or expert review of images/data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. The study described is mechanical testing, which does not involve human adjudication.

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

This information is not applicable and not provided in the document. The device is a surgical applicator (mechanical device), not an AI/software device that assists human readers in interpreting medical images or data.

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

This information is not applicable and not provided in the document. The device is a mechanical surgical applicator, not an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the mechanical testing would be the engineering specifications and performance metrics defined by the manufacturer and relevant industry standards for surgical instruments. The device's performance was evaluated against these predefined mechanical acceptance criteria.

8. The sample size for the training set

This information is not applicable and not provided in the document. As this is mechanical testing for a physical device, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided in the document. There is no training set mentioned or implied.

Summary of Device Performance Study and Conclusion:

The study performed was mechanical testing that simulated the insertion of the implant into an intervertebral body using the subject T-PAL Advanced Applicator. The purpose was to demonstrate that modifications to the applicator did not negatively impact its mechanical performance.

Conclusion: "The performance acceptance criteria was met." and "The insertion testing further demonstrates that the modifications to the design do not introduce any new questions of safety and effectiveness." The submission concludes that the T-PAL Advanced Applicator is substantially equivalent to the predicate devices.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters 'FDA' in white, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue. To the left of the FDA logo is the Department of Health & Human Services seal, which includes an emblem with a caduceus-like symbol and the text 'DEPARTMENT OF HEALTH & HUMAN SERVICES-USA' arranged around it.

December 6, 2018

DePuy Synthes Spine Ms. Rozanne Shirley Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

Re: K181231

Trade/Device Name: DePuy Synthes T-PAL Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 5, 2018 Received: November 6, 2018

Dear Ms. Shirley:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 0613012020 See PRA Statement below.

510(k) Number K181231

Device Name DePuy Synthes T-PAL Spacer System

Indications for Use (Describe)

The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.

Type of Use (Select one or both, as applicable) ×PrescriptionUse(Part21CFR801SubpartD) □ 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

"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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301

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510(k) Summary

A. Submitter Information

510(k) Sponsor:	Synthes USA, LLC1101 Synthes AvenueMonument, CO 80132 USA
Submitter:	DePuy Synthes Spine325 Paramount DriveRaynham, MA 02767
Contact Person:	Rozanne Shirley325 Paramount DriveRaynham, MA 02767
Telephone number:	(508) 977-6304
Email:	rshirle1@its.jnj.com
B. Date Prepared	December 6, 2018
C. Device Name
Trade/Proprietary Name:	DePuy Synthes T-PAL Spacer System
Common/Usual Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Classification Name:	Intervertebral Fusion, per 21 CFR 888.3080
Product Code:	MAX
Predicate Device Name

Primary Predicate Trade Name:	T-PAL Spacer System (K100089)
Additional Predicate Device:	DePuy Synthes T-PAL Ti Spacer System (K151276)

D. Device Description

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facilitate insertion of the T-PAL Spacer and final positioning in the interbody disc space.

E. Indications for Use

The T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The T-PAL Spacer is intended to be used with DePuy Synthes supplemental fixation.

F. Summary of Similarities and Differences in Technological Characteristics, and Intended Use The intended use, method of sterilization, fundamental scientific technology, and function of the T-PAL Advanced Applicator is identical to the predicate devices, K100089 and K151276. The T-PAL Advanced Applicator has similar but not identical design and performance as the current T-PAL Applicator, due to minor modifications to the handle and inner shaft. The main difference between the predicate device and the subject device includes a modification to the T-PAL Advanced Applicator inner shaft to now have a biased claw design with an elongated finger and a higher pivoting angle to allow for greater flexibility in the angle of approach and to facilitate implant release. The minor modification to the width of the distal end of the T-PAL Advanced Applicator Handle is to accommodate for the new inner shaft, and current implants and trial spacers. In addition, there is a minor design modification to the base material of the distal end of the handle. The predicate device will not be replaced by the subject device in the market.

G. Materials

The T-PAL Applicator and T-PAL Advanced Applicator are manufactured from a medical grade stainless steel. The material used to manufacture the T-PAL Advanced Applicator Inner Shaft is identical to the predicate. T-PAL Applicator Inner Shaft. The T-PAL Applicator and T-PAL Advanced Applicator Handles are composed of silicone rubber and stainless steel. The stainlesssteel material of the distal end of the T-PAL Advanced Applicator (outer shaft) is being modified from a 17-4 PH Stainless Steel to a Custom 465cw Stainless Steel. Other than this change, the materials and manufacturing of the subject device are identical to those of the predicate device.

H. Performance Data

The new T-PAL Advanced Applicator is a minor modification to the currently cleared T-PAL Applicator, the modification and does not change the fundamental scientific technology of the device. Based on a review of the performance data, the subject T-PAL Advanced Applicator does not represent a worst case from a mechanical testing standpoint. The mechanical testing simulated the insertion of the implant into an intervertebral body using the subject T-PAL Advanced Applicator. The performance acceptance criteria was met. The conclusion of the testing criteria demonstrates the subject device performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.

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I. Conclusion

The subject device, T-PAL Advanced Applicator, is substantially equivalent to the predicate devices because the intended use remains unchanged due to the changes to the device and technological characteristics of the subject device are similar to the predicate. The insertion testing further demonstrates that the modifications to the design do not introduce any new questions of safety and effectiveness.

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.