(166 days)
Not Found
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for spinal fusion procedures to treat conditions like degenerative disc disease, spondylolisthesis, and spinal deformities, which are therapeutic interventions.
No
The device description clearly states it is an interbody fusion device, a physical implant (spacer and plates) used in spinal fusion procedures. It is not described as assessing, diagnosing, or monitoring a patient's condition.
No
The device description explicitly states that the device is fabricated and manufactured from titanium alloy and consists of physical components like spacers, plates, and screws. It also mentions the use of standard orthopedic instruments for placement. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. It is used in the body to provide structural support and promote bone growth.
- Device Description: The device description details the materials (titanium alloy), physical form (spacer, plates, screws), and how it functions as a mechanical implant.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples like blood, urine, or tissue. This device is a surgical implant.
N/A
Intended Use / Indications for Use
When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the TruLift® Lateral Expandable Spacer can also be connected to the Lateral Plate System by a set screw.
The Lateral Plate System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
- Trauma (i.e., fracture or dislocation)
The Lateral Plate System, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. The Lateral Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw.
Product codes (comma separated list FDA assigned to the subject device)
MAX, KWQ
Device Description
The TruLift® Lateral Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Lateral Expandable Spacer System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer System components should never be reused under any circumstances.
The Lateral Plate System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The Lateral Plate System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
Do not use any of the Lateral Plate System components from any other system or manufacturer. The Lateral Plate System components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1, T1-L5
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)
Performance Data:
Plates
ASTM F1717 Dynamic Axial Compression Bending, Static Axial Compression Bending, Static Torsion
These test are equivalent Life Spine 2-Hole Lateral Plating System (K172131)
Interbody
ASTM F2077 Static Axial Compression, Static Compressive Shear, Dynamic Axial Compression and Dynamic Compressive Shear ASTM F2267 Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression These tests are equivalent Life Spine ProLift Expandable System (K191005).
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.
K191005, K201721, K210061, K201500, K202495, K172131
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2022
Life Spine Inc. Ms. Angela Batker RA/QA Manager 13951 S. Quality Drive Huntley, Illinois 60142
Re: K221806
Trade/Device Name: TruLift® Lateral Expandable Spacer System & Lateral Plate System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, KWQ Dated: November 7, 2022 Received: December 8, 2022
Dear Ms. Batker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 -S
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) K221806
Device Name
TruLift® Lateral Expandable Spacer System & Lateral Plate System
Indications for Use (Describe)
When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the TruLift® Lateral Expandable Spacer can also be connected to the Lateral Plate System by a set screw.
The Lateral Plate System is intended to be used as a non-pedicle lateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:
-
Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
-
-Spondylolisthesis
-
-Spinal stenosis
-
-Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
-
-Tumor
-
-Pseudoarthrosis
-
-Failed previous fusion
-
-Trauma (i.e., fracture or dislocation)
The Lateral Plate System, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. The Lateral Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw.
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.
C)
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4
K221806 510(k) Summary Trulift® Lateral Expandable Spacer System & Lateral Plate System
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | November 2, 2022 |
| Trade Name: | Trulift® Lateral Expandable Spacer System & Lateral Plate System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | MAX, CFR 888.3080, Class II
KWQ, CFR 888.3060, Class II |
| Primary Predicate: | Life Spine ProLift Expandable System (K191005) |
| Additional Predicate: | Life Spine TruLift Expandable System (K201721)
Life Spine ProLift HELO Expandable System (K210061)
Life Spine Plateau-X (K201500)
Sirion Lateral Lumbar Interbody Fusion (K202495)
Life Spine 2-Hole Lateral Plating System (K172131) |
Device Description:
The TruLift® Lateral Expandable Spacer System is available in a range of sizes and footprints and can expand to the desired height (8mm) to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are provided sterile and intended for SINGLE USE ONLY and should not be reused under any circumstances. Do not use any of the TruLift® Lateral Expandable Spacer System components with components from any other system or manufacturer. The TruLift® Lateral Expandable Spacer System components should never be reused under any circumstances.
5
The Lateral Plate System consists of a variety of plates and screws to suit the individual pathology and anatomical conditions of the patient. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.The plates are manufactured in a variety of configurations with options including different lengths and curvature. The screws are manufactured in variable and fixed configurations with diameters and lengths. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the Lumbar spine using an anterior approach. The responsible surgeon will determine the correct size of the implant in accordance with the size of the individual patient.
The Lateral Plate System also utilizes a variety of standard orthopedic instruments to assist in the placement of the devices.
Do not use any of the Lateral Plate System components from any other system or manufacturer. The Lateral Plate System components should never be reused under any circumstances.
Intended Use of the Device:
When used as an interbody fusion device, the TruLift® Lateral Expandable Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level(s) may be treated with the device. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The TruLift® Lateral Expandable Spacer can also be connected to the Lateral Plate System by a set screw.
The Lateral Plate System is intended to be used as a non-pedicle lateral or anterolateral fixation system in skeletally mature patients and is intended to provide immobilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic and lumbar spine. It may be used from levels T1-L5 with the following indications:
-Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
- Trauma (i.e., fracture or dislocation)
The Lateral Plate System, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during
6
spinal fusion. The 1-hole plate is not intended for use in load-bearing applications. The Lateral Plate System can also be connected to the TruLift® Lateral Spacer System by a set screw.
Technological Characteristics:
The Trulift® Lateral Expandable Spacer System is substantially equivalent to (ProLift Lateral K191005) in terms of design, materials, indications for use and sizing. The Lateral Plate System is substantially equivalent to the predicate systems in terms of indications to the Sirion Lateral Lumbar Interbody Fusion (K202495), substantially equivalent in design and materials to Life Spine 2-hole Lateral Plating System (K172131).
Material:
This submission seeks clearance of a device made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. This this is the same material used in the predicate devices.
Performance Data:
Plates
ASTM F1717 Dynamic Axial Compression Bending, Static Axial Compression Bending, Static Torsion
These test are equivalent Life Spine 2-Hole Lateral Plating System (K172131)
Interbody
ASTM F2077 Static Axial Compression, Static Compressive Shear, Dynamic Axial Compression and Dynamic Compressive Shear ASTM F2267 Induced Subsidence of Intervertebral Body Fusion Device under Static Axial Compression These tests are equivalent Life Spine ProLift Expandable System (K191005).
Substantial Equivalence:
The Trulift® Lateral Expandable Spacer System & Lateral Plate System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of the Trulift® Lateral Expandable Spacer System & Lateral Plate System.