Who is the manufacturer of Born PT-LIF Cage HA?

Spineworxx AG filed the 510(k) submission for Born PT-LIF Cage HA (K202380).

What is the FDA product code for Born PT-LIF Cage HA?

MAX. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Born PT-LIF Cage HA?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Born PT-LIF Cage HA?

Innovasis Px HA PEEK IBF System (K151785); Aleutian Spine System (K130699).

Who can help prepare an FDA 510(k) submission like Born PT-LIF Cage HA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Born PT-LIF Cage HA

K202380 · Spineworxx AG · MAX · Feb 19, 2021 · Orthopedic

Device Facts

Record ID	K202380
Device Name	Born PT-LIF Cage HA
Applicant	Spineworxx AG
Product Code	MAX · Orthopedic
Decision Date	Feb 19, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3080
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Interbody fusion device for lumbar/lumbosacral spine; replaces collapsed/unstable discs. Manufactured from PEEK-OPTIMA HA Enhanced with radiopaque markers. Features hollow center for bone graft, bullet nose for insertion, and serrated surfaces for fixation. Implanted via posterior or transforaminal approach by surgeons. Provides structural support and stabilization to facilitate fusion. Single-use; gamma-sterilized. Used with supplemental fixation. Benefits patients by restoring disc height and promoting spinal fusion in DDD cases.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 (static/dynamic axial compression, static/dynamic compression shear) and ASTM F2267 (subsidence, expulsion). Material stability and packaging validation also conducted.

Technological Characteristics

Materials: PEEK-OPTIMA HA Enhanced, Tantalum markers. Form factor: Hollow cage with serrated surfaces, bullet nose. Dimensions: 25-36mm length, 7-17mm height, 0-16° lordosis. Sterilization: Gamma radiation. Connectivity: None. Mechanical testing: ASTM F2077, ASTM F2267.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two levels (L2-S1), including those with up to grade 1 spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment. Used with autogenous bone graft and supplemental fixation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Innovasis Px HA PEEK IBF System (K151785)
Aleutian Spine System (K130699)

Related Devices

K240623 — Omnia Medical TiBrid-SA System · Omnia Medical, LLC · Apr 24, 2024
K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System · Curiteva, Inc. · Jan 18, 2024
K120991 — TRANS1 INTERBODY FUSION SYSTEM · Trans1 Incorporated · Aug 23, 2012
K193541 — NuVasive Cohere Thoracolumbar Interbody System · Nu Vasive, Incorporated · Mar 30, 2020
K131077 — LIFE SPINE PLATEAU SPACER SYSTEM · Life Spine · Jul 17, 2013

Submission Summary (Full Text)

{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) 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. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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 AG Schuppisstrasse 10 9016 St. Gallen Switzerland | |-----------------------------|-----------------------------------------------------------------------------------------------------| | 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 System The predicate device has never been subject to recall. | | Additional Predicate: | K130699- Aleutian Spine System The additional predicate device has never been subject to recall. | ### 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. ### Intended Use: 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. {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 Comparison SpineworxX AG PT-LIF Cage | Innovasis Px PEEK IBF | Aleutian (Additional) | Equivalence | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | Classification Name | Intervertebral Fusion Device With Bone Graft, Lumbar | Intervertebral Fusion Device With Bone Graft, Lumbar | Intervertebral Fusion Device With Bone Graft, Lumbar | Equivalent | | Regulation | 888.3080 | 888.3080 | 888.3080 | Equivalent | | Common Name | Intervertebral body fusion device | Intervertebral body fusion device | Intervertebral body fusion device | Equivalent | | Product Code | MAX | MAX | MAX | Equivalent | | Intended Use | 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 | The Innovasis Px HATM PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). 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 at least six (6) months of non- operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis | Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non- operative treatment. Aleutian implants are intended to be used with supplemental | Equivalent | | SPINEWORXX | | | | | | | 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. | the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior (PLIF) or modified transforaminal (T- PLIF) approach. This device is intended to be used in pairs and with internal supplemental spinal fixation systems such as the Innovasis Excella® Spinal System. The interior of the Px HA implant is intended to be packed with autograft. | | | | 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 | The Innovasis Px HATM PEEK IBF is designed for use in a posterior (PLIF) approach to the lumbar spine. Implants are manufactured by Innovasis from Invibio® PEEK- OPTIMA® HA Enhanced*. Hydroxyapatite (HA) is fully integrated into the ΡΕΕΚΟΡΤΙΜΑ. The device is radiolucent allowing straightforward assessment of the | The Aleutian spinal system consists of a hollow tube or horseshoe shaped structures manufactured from medical grade PEEK (polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body endplates. The implants are manufactured from | Equivalent | | SPINEWORXX | | | | | | | 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 heights, and degrees of lordosis. 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. | while tantalum spheres are located around the periphery of the device to allow implant visualization during and after surgery. The single use implant devices feature an open cavity in the interior geometry to accommodate bone graft and maximize bone in- growth, with anti- migration teeth to engage the vertebral endplates and prevent expulsion. The implants have a slightly convex profile and are offered in a variety of different sizes to fit the anatomical needs of a wide variety of patients. The implant has a tapered leading edge which aids in implant insertion due to limited anatomical space. Reusable instruments to support the PLIF surgery are provided with the implants in custom sterilization trays. | ASTM 2026. Tantalum beads/rods are made of Grade UNS R05200, UNS R05400 according to ASTM F560. The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine. | | | Sizes | Heights: 8-17 in 1mm increments | Heights: 8-16mm in 1mm increments | Heights: 4-12mm in 1mm increments Lengths: 24-28mm | Equivalent- largest SpineworxX | | | Lengths: 25, 28, 32, 36mm Width: 10mm Lordosis: 0, 4, 8, 12, 16° | Lengths: 22, 28, 32mm Widths: 8,10,12mm Lordosis: 0°, 5° | Width: 8.5mm Lordosis: 6,12,18° | size demonstrated equivalence in mechanical testing | | Graft Window | Yes | Yes | Yes | Equivalent | | Anti-Migration Features | Yes | Yes | Yes | Equivalent | | Use with Supplemental Fixation | Yes | Yes | Yes | Equivalent | | Material | PEEK- OPTIMA™ HA Enhanced, Tantalum | PEEK- OPTIMA™ HA Enhanced, Tantalum | PEEK-OPTIMA LT1, Tantalum | Equivalent | | Mechanical Testing | Performance testing per ASTM F2077-11 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence, Expulsion | Performance testing per ASTM F2077-11 and F2267-04 for Static Axial Compression, Dynamic Axial Compression, Subsidence and Expulsion | Performance testing per ASTM F2077 for static compression, static torsion and dynamic 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.