(183 days)
Not Found
No
The device description and performance studies focus solely on the mechanical and material properties of a physical implant (interbody fusion cage). There is no mention of software, algorithms, data processing, or any characteristics typically associated with AI/ML.
Yes
The device is used to treat degenerative disc disease (DDD) and replaces a collapsed, damaged, or unstable disc in the spine, which aligns with the definition of a therapeutic device.
No
The device is an interbody fusion cage designed to replace a damaged disc in the spine; it is a therapeutic implant, not a diagnostic device.
No
The device description clearly states it is a physical interbody fusion device manufactured from PEEK-OPTIMA™ HA Enhanced, with specific dimensions and features, and requires surgical implantation. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Born PT-LIF Cage HA is an implantable surgical device. It is physically inserted into the body to replace a damaged disc and facilitate bone fusion. It does not analyze biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by implanting a cage. It does not involve any diagnostic testing of bodily fluids or tissues.
The information provided describes a medical device used in surgery, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine from L2 to S1, lumbar or lumbosacral vertebral bodies
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
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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.
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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.
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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
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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.