The Born PT-LIF Cage HA is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels of the spine from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted in open surgery via a posterior or transforaminal approach. These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbosacral spine.

Device Description

The Born PT-LIF Cage HA is an interbody fusion device which is inserted between two lumbar or lumbosacral vertebral bodies to replace a collapsed, damaged, or unstable disc. The cage is manufactured from PEEK-OPTIMA™ HA Enhanced. The cage contains a hollow center to allow for bone graft packing, and radiopaque positioning markers. The cage is designed with a bullet nose for easier insertion and serrated contact surfaces for fixation and stability. The device is available in different lengths (25, 28, 32, 36mm), heights (7-17mm in 1mm increments), and degrees of lordosis (0, 4, 8, 12, 16°). All cages are 10mm wide. The Born PT-LIF Cage HA shall be used with autogenous bone graft and supplemental fixation. The cages are single use devices, which are sterilized via gamma radiation and provided to the user in sterile packages. The instruments used to insert the cage are manufactured from medical grade stainless steel and must be sterilized prior to use.

AI/ML Overview

The provided document describes a medical device, the Born PT-LIF Cage HA, and its substantial equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about a study proving the device meets acceptance criteria based on clinical performance, nor does it include details typically found in studies involving AI such as sample sizes for test and training sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than efficacy or clinical performance against specific acceptance criteria in the manner described in the prompt.

However, it does describe non-clinical mechanical testing and sets acceptance criteria based on standard ASTM tests for intervertebral body fusion devices.

Here's a breakdown of the available information relevant to your request, adapted to the non-clinical context provided:

Acceptance Criteria and Reported Device Performance (Non-Clinical Mechanical Testing)

The document outlines mechanical testing performed to demonstrate the substantial equivalence of the Born PT-LIF Cage HA. The acceptance criteria for these tests are implicitly that the device performs comparably to or better than the predicate devices and meets the requirements of the referenced ASTM standards.

Acceptance Criteria (Implicit from ASTM Standards)	Reported Device Performance (Born PT-LIF Cage HA)
Mechanical Performance (per ASTM F2077 and F2267-04):	The results of each of the conducted mechanical tests met their respective acceptance criteria. This implies the device performed adequately and comparably to predicate devices under these conditions.
Dynamic Axial Compression: Device must withstand cyclic axial loading without failure or excessive deformation, demonstrating fatigue resistance and structural integrity.	Successfully met acceptance criteria.
Dynamic Compression Shear: Device must withstand cyclic shear loading without failure or excessive deformation.	Successfully met acceptance criteria.
Static Axial Compression: Device must withstand static axial load without catastrophic failure or excessive deformation.	Successfully met acceptance criteria.
Static Compression Shear: Device must withstand static shear load without catastrophic failure or excessive deformation.	Successfully met acceptance criteria.
Static Subsidence: Device must demonstrate resistance to subsidence (sinking) into vertebral bone under static loading, as measured by relevant metrics (e.g., deformation under load).	Successfully met acceptance criteria.
Expulsion: Device must resist expulsion (dislodgement) from the vertebral body, demonstrating adequate fixation features.	Successfully met acceptance criteria.
Material Stability: No significant effect on material properties due to sterilization and aging (based on thermal transitions, crystallinity, FTIR, density, extractables, and leachables).	Testing demonstrated that sterilization and aging did not have a significant effect on the material. Biocompatibility was ascertained.
Packaging Validation: Packaging must maintain sterility and integrity after shipping, handling, and sterilization (visual inspection, peel strength, dye leak testing).	All test samples met the acceptance criteria, demonstrating that the package adequately maintains the sterility of the device.

Regarding the specific points requested for a clinical/AI study, the provided document does NOT contain the following information:

Sample sizes used for the test set and the data provenance: Not applicable to this non-clinical mechanical testing report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 document is for a physical medical implant, not an AI diagnostic/assistive device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is defined by the performance requirements and established methods of the relevant ASTM standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of available non-clinical study information:

Study Title/Purpose: Non-clinical (Mechanical, Material, Packaging) Testing to support Substantial Equivalence for the Born PT-LIF Cage HA.
Tests Conducted (Implicit acceptance criteria source):
- Dynamic Axial Compression (per ASTM F2077)
- Dynamic Compression Shear (per ASTM F2077)
- Static Axial Compression (per ASTM F2077)
- Static Compression Shear (per ASTM F2077)
- Static Subsidence (per ASTM F2267-04)
- Expulsion
- Material stability (thermal transitions, crystallinity, FTIR, density, extractables, leachables)
- Packaging validation (visual inspection, peel strength, dye leak testing)
Sample Size for Test Set (Mechanical): The mechanical tests were conducted on the "largest (17mm height) cages," and Dynamic Axial Compression was also done on 8mm height cages. The exact number of units tested per condition is not specified but it implies multiple units were used to meet scientific rigor.
Data Provenance: The testing was presumably conducted by SpineworxX AG or their contracted labs. The data is retrospective to the submission date.
Ground Truth (for non-clinical tests): Defined by the referenced ASTM standards (F2077 and F2267-04) and internal specifications for material stability and packaging integrity.
Training Set: Not applicable as this is not an AI device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

February 19, 2021

SpineworxX AG % Cassandra Petrov Regulatory Engineer JALEX Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K202380

Trade/Device Name: Born PT-LIF Cage HA Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 22, 2021 Received: January 25, 2021

Dear Cassandra Petrov:

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

{1}------------------------------------------------

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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202380

Device Name Born PT-LIF Cage HA

Indications for Use (Describe)

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

"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."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows a logo for a company called SPINEWORXX. The logo consists of a pink circle with a white stylized letter 'B' inside. The letter 'B' is formed by three horizontal lines, with the middle line being shorter than the other two. The text 'SPINEWORXX' is written in a small, sans-serif font below the circle.

510(k) Summary

Submitted By:	SpineworxX AGSchuppisstrasse 109016 St. GallenSwitzerland
Date:	July 13, 2020
Contact Person:	Cassandra Petrov, Regulatory Engineer
Contact Telephone:	(440) 541-0060
Contact Fax:	(440) 933-7839
Device Trade Name:	Born PT-LIF Cage HA System
Device Classification Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Device Classification:	Class II
Reviewing Panel:	Orthopedic
Product Code:	MAX
Predicate Device:	K151785- Innovasis Px HA PEEK IBF SystemThe predicate device has never been subject to recall.
Additional Predicate:	K130699- Aleutian Spine SystemThe additional predicate device has never been subject to recall.

Device Description:

Intended Use:

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows a logo for a company called SPINEWORXX. The logo consists of a pink circle with a stylized white "S" inside. The text "SPINEWORXX" is written in small, gray letters below the circle.

Summary of Technological Characteristics:

Item	Table 1. Technological Characteristics ComparisonSpineworxX AGPT-LIF Cage	Innovasis PxPEEK IBF	Aleutian (Additional)	Equivalence
ClassificationName	IntervertebralFusion DeviceWith Bone Graft,Lumbar	IntervertebralFusion DeviceWith Bone Graft,Lumbar	Intervertebral FusionDevice With BoneGraft, Lumbar	Equivalent
Regulation	888.3080	888.3080	888.3080	Equivalent
Common Name	Intervertebralbody fusion device	Intervertebralbody fusiondevice	Intervertebral bodyfusion device	Equivalent
Product Code	MAX	MAX	MAX	Equivalent
Intended Use	The Born PT-LIFCage HA isindicated for usewith autogenousbone graft inpatients withdegenerative discdisease (DDD) atone or two levelsof the spine fromL2 to S1. TheseDDD patients mayalso have up tograde 1spondylolisthesisor retrolisthesis atthe involvedlevels. DDD isdefined asdiscogenic backpain withdegeneration ofthe disc confirmedby history andradiographicstudies. Thesepatients should beskeletally matureand have had sixmonths of non-operativetreatment. These	The Innovasis PxHATM PEEK IBFSystem is anintervertebralbody fusiondevice for use inpatients withdegenerative discdisease (DDD) atone or twocontiguous levelsof the lumbarspine (L2-S1).DDD is defined asdiscogenic backpain withdegeneration ofthe disc confirmedby history andradiographicstudies. Thesepatients should beskeletally matureand have had atleast six (6)months of non-operativetreatment. Inaddition, thesepatients may haveup to a Grade 1spondylolisthesis	Aleutian implants areindicated for spinalfusion procedures to beused with autogenousbone graft in skeletallymature patients. Thelumbar IBF implantsare intended for use ateither one level or twocontiguous levels inthe lumbar spine, fromL2 to S1, for thetreatment ofdegenerative discdisease (DDD) with upto Grade 1spondylolisthesis.DDD is defined asback pain ofdiscogenic origin withdegeneration of thedisc confirmed byhistory andradiographic studies.The lumbar device isintended to be used inpatients who have hadsix months of non-operative treatment.Aleutian implants areintended to be usedwith supplemental	Equivalent
SPINEWORXX
	implanted in opensurgery via aposterior ortransforaminalapproach. Thesedevices areintended to beused withsupplementalfixation which hasbeen cleared foruse in thelumbosacral spine.	the involvedlevel(s). Theseimplants are usedto facilitate fusionin the lumbarspine and areplaced via either aposterior (PLIF)or modifiedtransforaminal (T-PLIF) approach.This device isintended to beused in pairs andwith internalsupplementalspinal fixationsystems such asthe InnovasisExcella® SpinalSystem. Theinterior of the PxHA implant isintended to bepacked withautograft.
Description	The Born PT-LIFCage HA is aninterbody fusiondevice which isinserted betweentwo lumbar orlumbosacralvertebral bodies toreplace acollapsed,damaged, orunstable disc. Thecage ismanufacturedfrom PEEK-OPTIMA™ HAEnhanced. Thecage contains ahollow center toallow for bonegraft packing and	The Innovasis PxHATM PEEK IBFis designed for usein a posterior(PLIF) approachto the lumbarspine. Implantsare manufacturedby Innovasis fromInvibio® PEEK-OPTIMA® HAEnhanced*.Hydroxyapatite(HA) is fullyintegrated into theΡΕΕΚΟΡΤΙΜΑ.The device isradiolucentallowingstraightforwardassessment of the	The Aleutian spinalsystem consists of ahollow tube orhorseshoe shapedstructuresmanufactured frommedical grade PEEK(polyetheretherketone).The devices areavailable in a varietyof different sizes andheights to match moreclosely the patient'sanatomy. The ends ofthe implants havemachined teeth whichare designed to engagewith the vertebral bodyendplates. Theimplants aremanufactured from	Equivalent
SPINEWORXX
	positioningmarkers. The cageis designed with abullet nose foreasier insertionand serratedcontact surfacesfor fixation andstability. Thedevice is availablein different lengthsheights, anddegrees oflordosis. The BornPT-LIF Cage HAshall be used withautogenous bonegraft andsupplementalfixation. Thecages are singleuse devices, whichare sterilized viagamma radiationand provided tothe user in sterilepackages. Theinstruments usedto insert the cageare manufacturedfrom medicalgrade stainlesssteel and must besterilized prior touse.	while tantalumspheres arelocated around theperiphery of thedevice to allowimplantvisualizationduring and aftersurgery. Thesingle use implantdevices feature anopen cavity in theinterior geometryto accommodatebone graft andmaximize bone in-growth, with anti-migration teeth toengage thevertebralendplates andprevent expulsion.The implants havea slightly convexprofile and areoffered in avariety of differentsizes to fit theanatomical needsof a wide varietyof patients. Theimplant has atapered leadingedge which aids inimplant insertiondue to limitedanatomical space.Reusableinstruments tosupport the PLIFsurgery areprovided with theimplants incustomsterilization trays.	ASTM 2026.Tantalum beads/rodsare made of GradeUNS R05200, UNSR05400 according toASTM F560. Thesystem functions as anintervertebral bodyfusion device toprovide support andstabilization of thelumbar segments of thespine.
Sizes	Heights: 8-17 in1mm increments	Heights: 8-16mmin 1mmincrements	Heights: 4-12mm in1mm incrementsLengths: 24-28mm	Equivalent-largestSpineworxX
	Lengths: 25, 28,32, 36mmWidth: 10mmLordosis: 0, 4, 8,12, 16°	Lengths: 22, 28,32mmWidths:8,10,12mmLordosis: 0°, 5°	Width: 8.5mmLordosis: 6,12,18°	sizedemonstratedequivalence inmechanicaltesting
Graft Window	Yes	Yes	Yes	Equivalent
Anti-MigrationFeatures	Yes	Yes	Yes	Equivalent
Use withSupplementalFixation	Yes	Yes	Yes	Equivalent
Material	PEEK-OPTIMA™ HAEnhanced,Tantalum	PEEK-OPTIMA™ HAEnhanced,Tantalum	PEEK-OPTIMA LT1,Tantalum	Equivalent
MechanicalTesting	Performancetesting per ASTMF2077-11 andF2267-04 forStatic AxialCompression,Dynamic AxialCompression,Subsidence,Expulsion	Performancetesting per ASTMF2077-11 andF2267-04 forStatic AxialCompression,Dynamic AxialCompression,Subsidence andExpulsion	Performance testingper ASTM F2077 forstatic compression,static torsion anddynamic compression.	Equivalent

Table 1, Technological Characteristics Comparison

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows a logo for a company called SPINEWORXX. The logo consists of a pink circle with a stylized white "B" inside. The text "SPINEWORXX" is written in a small, sans-serif font below the circle.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows a logo for a company called SPINEWORXX. The logo consists of a pink circle with a white stylized "B" inside. The text "SPINEWORXX" is written in gray below the circle.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows a logo for a company called "Spineworxx". The logo features a pink circle with a white stylized "S" inside. The word "Spineworxx" is written in gray, block letters below the circle.

Non-clinical Testing:

Mechanical:

The following mechanical tests were conducted on the largest (17mm height) cages:

Dynamic Axial Compression per ASTM F2077 (also conducted on 8mm height)
Dynamic Compression Shear per ASTM F2077
Static Axial Compression per ASTM F2077
. Static Compression Shear per ASTM F2077
Static Subsidence per ASTM F2267-04
Expulsion ●

The results of each of the above tests met their respective acceptance criteria and further support the substantial equivalence of the device. Further details on the mechanical testing of this device are provided within this submission.

Material Stability:

The PEEK-OPTIMA™ HA Enhanced material was tested by the material supplier for thermal transitions, estimated crystallinity, chemical composition by FTIR, density, extractables and leachables to ascertain the biological safety of the device. Testing demonstrated that sterilization and aging did not

{8}------------------------------------------------

K202380 Page 6 of 6

Image /page/8/Picture/1 description: The image shows a logo for a company called SPINEWORXX. The logo consists of a pink circle with a white stylized "S" inside. The text "SPINEWORXX" is written in a small, sans-serif font below the circle.

have a significant effect on the material. Further information on stability testing is provided within this submission.

Packaging Validation:

A packaging validation was conducted on the implant pouch after shipping and handling conditioning and sterilization. Visual inspection, peel strength and dye leak testing were performed on the packages. All test samples met the acceptance criteria demonstrating that the package adequately maintains the sterility of the device.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

Regulation Number and Section

N/A