(110 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a lumbar interbody fusion system intended for surgical implantation to facilitate fusion in the spine, which is a therapeutic purpose.
No
The device is an intervertebral body fusion system, intended to replace a damaged disc and provide mechanical support for fusion, rather than to diagnose a condition.
No
The device description clearly states it is comprised of physical components (intervertebral body fusion systems) made of materials and designed to provide mechanical support, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intervertebral body fusion of the lumbar spine. This is a surgical procedure involving the implantation of a device to facilitate bone fusion.
- Device Description: The device is a physical implant designed to provide mechanical support and aid in fusion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Product codes
MAX
Device Description
The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine to replace a collapsed, damaged, or unstable disc. The 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options, and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
Indicated Patient Age Range
skeletally mature patients
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 Testing: Substantial equivalence is supported by the results of mechanical testing, including static axial compression, static axial compression-shear, dynamic axial compression, dynamic axial compression-shear per ASTM F2077, subsidence per ASTM F2267, and expulsion. Results support that the subject device performs as well as or better than the chosen acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Eminent Spine Interbody Fusion System (K090064), Eminent Spine 3D Cervical Interbody Fusion System (K212701), CancelleX Porous Titanium Lumbar Interbody Device (K190364)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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May 16, 2023
Eminent Spine, LLC % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd. Suite 3 Westlake, Ohio 44145
Re: K230219
Trade/Device Name: Eminent Spine 3D Lumbar Interbody Fusion Systems Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 14, 2023 Received: March 14, 2023
Dear Jennifer Palinchik:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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. Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230219
Device Name
Eminent Spine 3D Lumbar Interbody Fusion Systems
Indications for Use (Describe)
The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| \ 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/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a spine-like design in the center, surrounded by a golden, curved shape. The text "EMINENT" is displayed above the word "SPINE" in a smaller font size.
510(k) Summary
| Submitted By: | Eminent Spine, LLC
2004 Ventura Dr. Suite #100
Plano, TX 75093 | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------|--|--|
| Date: | 05/15/2023 | | |
| Contact Person: | Jennifer Palinchik, President, JALEX Medical | | |
| Contact Telephone: | (440) 935-3282 | | |
| Contact Fax: | (440) 933-7839 | | |
| Device Trade Name: | Eminent Spine 3D Lumbar Interbody Fusion Systems | | |
| Common Name: | Intervertebral Body Fusion Device | | |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft, Lumbar | | |
| Device Classification: | Class II | | |
| Reviewing Panel: | Orthopedic | | |
| Product Code: | MAX | | |
| Primary Predicate Device: | Eminent Spine Interbody Fusion System (K090064) | | |
| Additional Predicate Devices: | Eminent Spine 3D Cervical Interbody Fusion System (K212701)
CancelleX Porous Titanium Lumbar Interbody Device (K190364) | | |
Device Description:
The Eminent Spine 3D Lumbar Interbody Fusion Systems are intervertebral body fusion systems used in the spine to replace a collapsed, damaged, or unstable disc. The 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options, and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.
Indications for Use:
The Eminent Spine 3D Lumbar Interbody Fusion Systems (PLIF, TLIF, and ALIF) are indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and autograft to facilitate fusion. Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
Summary of Technological Characteristics:
The Eminent Spine 3D Lumbar Interbody Fusion Systems and the predicates have the same intended use and fundamental scientific technology. All devices compare similarly in:
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Image /page/4/Picture/1 description: The image shows a logo for "Eminent Spine". The logo features a golden spine with a sword running through it, surrounded by a golden arch. The text "EMINENT" is written above the text "SPINE" in a smaller font.
- Design features .
- Intended use
- Materials ●
- Dimensions .
- Function ●
Table 1: Dimensions and Technological Characteristics Comparison
| Item | Eminent Spine 3D
Lumbar Interbody
Fusion Systems | Eminent Spine
Interbody Fusion
System (K090064) | Eminent Spine 3D
Cervical Interbody
Fusion System
(K212701) | Comparison |
|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Classification
Name | Intervertebral Body
Fusion Device | Intervertebral Body
Fusion Device | Intervertebral Body
Fusion Device | Equivalent |
| Regulation | 888.3080 | 888.3080 | 888.3080 | Equivalent |
| Product Code | MAX | MAX, MQP, ODP | ODP | Intervertebral
body fusion
device code
equivalent to
primary
predicate |
| Indications for
Use | The Eminent Spine 3D
Lumbar Interbody
Fusion Systems (PLIF,
TLIF, and ALIF) are
indicated for
intervertebral body
fusion of the lumbar
spine, from L2 to S1, in
skeletally mature
patients who have had
six months of non-
operative treatment.
The device is intended
for use at either one
level or two contiguous
levels for the treatment
of degenerative disc
disease (DDD) with up
to Grade I
spondylolisthesis. DDD
is defined as back pain
of discogenic origin
with degeneration of
the disc confirmed by
history and
radiographic studies.
The device system is
designed for use with
supplemental fixation
and autograft to
facilitate fusion. | The Eminent Spine
Interbody Fusion
System (Sidewinder,
Python and
Cottonmouth) is
indicated for
intervertebral body
fusion of the lumbar
spine, from L2 to S1, in
skeletally mature
patients who have had
six months of non-
operative treatment.
The device is intended
for use at either one
level or two contiguous
levels for the treatment
of degenerative disc
disease (DDD) with up
to Grade I
spondylolisthesis. DDD
is defined as back pain
of discogenic origin
with degeneration of
the disc confirmed by
history and
radiographic studies.
The device system is
designed for use with
supplemental fixation | The Eminent Spine 3D
Cervical Interbody
Fusion System is
indicated for
intervertebral body
fusion in skeletally
mature patients with
degenerative disc
disease (DDD) of the
cervical spine at one
disc level from the C2-
C3 disc to the C7-T1
disc. DDD is defined as
discogenic pain with
degeneration of the disc
confirmed by history
and radiographic
studies. The device
system is designed for
use with supplemental
fixation and autograft to
facilitate fusion.
Patients should have at
least six (6) weeks of
non-operative treatment
prior to treatment with
an intervertebral cage. | Intervertebral
body fusion
indications
equivalent to
primary
predicate |
| | | | | |
| Hyperlordotic interbody
devices (≥20° lordosis)
must be used with at
least anterior
supplemental fixation. | and autograft to
facilitate fusion.
The Eminent Spine
System of implants is
indicated for use to
replace a vertebral body
that has been resected
or excised (i.e. partial
or total vertebrectomy)
due to tumor or
trauma/fracture. The
implant is intended for
use in the
thoracolumbar spine
(from T1 to L5) and is
intended for use with
supplemental internal
fixation and autograft
or allograft bone. These
devices are designed to
restore the
biomechanical integrity
of the anterior, middle
and posterior spinal
column even in the
absence of fusion for a
prolonged period. | | | |
| Description | The Eminent Spine 3D
Lumbar Interbody
Fusion Systems are
intervertebral body
fusion systems used in
the spine to replace a
collapsed, damaged, or
unstable disc. The 3D
Lumbar Interbody
Fusion Systems (PLIF,
TLIF, and ALIF) are
comprised of various
sizes and configurations
to accommodate
individual patient
anatomy. The
configurations are
designed to provide the
surgeon with different
surgical approach
options, and packed
with autogenous bone
graft to facilitate fusion. | The Eminent Spine
Interbody Fusion
System is comprised of
various sizes and
configuration to
accommodate
individual patient
anatomy. The
configurations are
designed to provide the
surgeon with different
surgical approach
options. | The Eminent Spine 3D
Cervical Interbody
Fusion System is
comprised of various
sizes and configuration
to accommodate
individual patient
anatomy. The device is
a hollow rectangular
shaped block, which is
available in a parallel or
lordotic configurations.
The device is hollow to
allow for placement of
bone graft. There are
teeth on the superior
and inferior surfaces of
the device to inhibit
movement of the
device. | Equivalent to
primary
predicate |
| | | | | |
| | surfaces of each device
grip the endplates of the
adjacent vertebral
bodies to aid in
expulsion resistance.
The device is intended
to provide mechanical
support to the
implanted level until
biologic fusion is
achieved. | | | |
| Footprints | PLIF: 22-31 mm x 9-12
mm
TLIF: 28-34 mm x 11
mm
ALIF: 32-42 mm x 21-
28 mm | Python (PLIF): 22-31
mm x 9-12 mm
Sidewinder (TLIF): 28-
31 mm x 11 mm
Cottonmouth (ALIF):
32-42 mm x 21-28 mm | 14x12 mm, 15x13 mm,
17x12 mm,
17x14 mm, 19x16 mm | Equivalent to
primary
predicate |
| Heights | PLIF: 6-18 mm
TLIF: 6-18 mm
ALIF: 10-20 mm | Python (PLIF): 6-18
mm
Sidewinder (TLIF): 6-
18 mm
Cottonmouth (ALIF):
10-20 mm | 5-12 mm | Equivalent to
primary
predicate |
| Lordotic angle | 6°, 12°, 18°, 24°, 30°
(depending on model) | 6°, 12°, 18°, 24°, 30°
(depending on model) | 0°, 6° | Equivalent to
primary
predicate |
| Material | Ti-6Al-4V per ASTM
F3001 | PEEK Optima LT1 and
Ti-6Al-4V ELI per
ASTM F136 | Ti-6Al-4V per ASTM
F3001 | Equivalent to
additional
predicate |
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Image /page/5/Picture/0 description: The image shows a logo for "Eminent Spine". The logo features a golden sword with a twisted blade, positioned vertically. The sword is surrounded by a golden, semi-circular frame, and the words "EMINENT SPINE" are written in a serif font below the sword.
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Image /page/6/Picture/1 description: The image shows a logo for "Eminent Spine". The logo features a golden spine with a sword running through it, surrounded by a golden, curved frame. The text "EMINENT" is written in a serif font above the word "SPINE", which is in a smaller font.
Mechanical Testing:
Substantial equivalence is supported by the results of mechanical testing, including static axial compression, static axial compression-shear, dynamic axial compression, dynamic axial compressionshear per ASTM F2077, subsidence per ASTM F2267, and expulsion. Results support that the subject device performs as well as or better than the chosen acceptance criteria.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.