(71 days)
Not Found
No
The device description focuses on the mechanical and surface properties of the implant, with no mention of AI or ML for analysis, diagnosis, or treatment planning.
Yes
The device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease and multilevel degenerative scoliosis, facilitating fusion and providing support and correction to the spine, which aligns with the definition of a therapeutic device.
No
The device is an implantable intervertebral body fusion device used to support and correct the spine during fusion surgeries, not to diagnose a condition.
No
The device description clearly states it is a physical, surgically implanted interbody device made of titanium alloy, not software.
Based on the provided text, the device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgically implanted device used to facilitate fusion in the lumbar spine. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy, designed to provide support and correction during surgery. It mentions surface treatments to improve bone fixation, which is related to the device's function within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside the body to provide information for diagnosis, monitoring, or screening.
Therefore, the Catalyft™ LS Expandable Interbody System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyft™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and supplemental fixation.
Product codes
MAX, OVD
Device Description
The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology consists of new interbody implants that are provided sterile and are intended to be surgically implanted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar intervertebral body fusion.
The Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology is an expandable titanium alloy interbody device consisting of expandable interbodies of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
The interbody device is a line extension to add Titan nanoLOCK™ Surface Technology to recently cleared Catalyft™ LS Expandable Interbody System (K212653, S.E. 11/19/2021). The subject interbody incorporates Titan Surface Technologies™, where superior and inferior surfaces include nanoLOCK™ surface treatments designed to improve bone fixation to adjacent bone. nanoLOCK™ surface technology provides a microscopic roughened surface with nano-scale features. nanoLOCK™ Surface Technology is specifically engineered to have nano textured features at a nanometer (10-9) level, which has demonstrated the ability to elicit an endogenous cellular and biochemical response attributed to these nanotextured features in vitro. nanoLOCK™ surface technology demonstrates elements to be considered nanotechnology as outlined in the FDA nanotechnology guidance document.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1), lumbosacral vertebral bodies
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)
The subject CatalyftTM LS nanoLOCKTM implants underwent the following verification tests: Static and Dynamic Compression per ASTM F2077-18 Static and Dynamic Compression Shear per ASTM F2077-18 Subsidence per ASTM F2267-04(2018) Expulsion testing Wear Debris per ASTM F1877 (2016) MRI Safety Evaluation per ASTM 2503-20, ASTM F2182-19e, ASTM 2052-21, F2213-17, F2219-07
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K212653, K214010, K094025, K133216, K171031, K100175, K132897, K133577, K142559
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.
0
Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 16, 2022
Medtronic Sofamor Danek USA, Inc. Alex Underberg Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K223153
Trade/Device Name: Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: October 4, 2022 Received: October 6, 2022
Dear Alex Underberg:
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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology
Indications for Use (Describe)
The Catalyft™ LS Expandable Interbody System device, including those with or without micro- and nano-roughened surface textured features, is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the Catalyft™ LS Expandable Interbody System can be used with patients diagnosed with multilevel degenerative scoliosis and sagittal deformities as an adjunct to fusion. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditional supplemental fixation (e.g. posterior fixation) must be used. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants may be implanted via a variety of open or minimally invasive anterior or oblique approach. The Catalyft™ LS Expandable Interbody System device may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Catalyfi™ LS Expandable Interbody System device is intended to be used with 4 titanium alloy screws. If the physician chooses to use less than 4 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 20° are intended to be used with 4 screws and 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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510(k) Summary
MEDTRONIC
Catalyft™ LS Expandable Interbody System with Titan nanoLOCK™ Surface Technology
December 8th, 2022
| Submitter | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132 |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Alex Underberg
Senior Regulatory Affairs Specialist
Email: alex.r.underberg@medtronic.com
Telephone: (901) 344-1443
Fax: (901) 346-9738 |
| Date Prepared | December 8th, 2022 |
| Name of Device | Catalyft™ LS Expandable Interbody System with Titan
nanoLOCK™ Surface Technology |
| Common Name | Interbody Cages |
| Classification Name | Intervertebral Body Lumbar Fusion Device with Bone Graft (21
CFR 888.3080) |
| Classification | Implants: Class II |
| Product Codes | MAX (888.3080)
OVD (888.3080) |
| Predicate Devices | Predicate 1 (Primary Predicate): Catalyft™ LS Expandable
Interbody System (K212653, S.E. 11/19/2021)
Predicate 2: Anteralign LS™ Interbody System with Titan
nanoLOCK™ Surface Technology (K214010, S.E. 04/12/2022)
Predicate 3: Crescent™ PEEK (K094025, S.E. 04/26/2010;
K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017) |
| | 06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014) |
| | Predicate 5: Elevate™ Spinal System (K142559, S.E. 06/09/2015) |
| | The Catalyft™ LS Expandable Interbody System with Titan
nanoLOCK™ Surface Technology consists of new interbody
implants that are provided sterile and are intended to be surgically
implanted between two lumbar or lumbosacral vertebral bodies to
give support and correction during lumbar intervertebral body
fusion. |
| Description | The Catalyft™ LS Expandable Interbody System with Titan
nanoLOCK™ Surface Technology is an expandable titanium alloy
interbody device consisting of expandable interbodies of various
widths, lengths, heights, and lordotic angles to accommodate
patient anatomy. These devices can be inserted between two
lumbar or lumbosacral vertebral bodies to give support and
correction during lumbar interbody fusion surgeries. Implants
have a central cavity that allows them to be packed with
autogenous bone graft and/or allograft bone graft comprised of
cancellous and/or corticocancellous bone, and/or demineralized
allograft bone with bone marrow aspirate. |
| | The interbody device is a line extension to add Titan
nanoLOCK™ Surface Technology to recently cleared Catalyft™
LS Expandable Interbody System (K212653, S.E. 11/19/2021).
The subject interbody incorporates Titan Surface Technologies™,
where superior and inferior surfaces include nanoLOCK™ surface
treatments designed to improve bone fixation to adjacent bone.
nanoLOCK™ surface technology provides a microscopic
roughened surface with nano-scale features. nanoLOCK Surface
Technology is specifically engineered to have nano textured
features at a nanometer (10-9) level, which has demonstrated the
ability to elicit an endogenous cellular and biochemical response
attributed to these nanotextured features in vitro . nanoLOCK
surface technology demonstrates elements to be considered
nanotechnology as outlined in the FDA nanotechnology guidance
document. |
| Indications for Use | The Catalyft™ LS Expandable Interbody System device,
including those with or without micro- and nano-roughened
surface textured features, is indicated for use as an
intervertebral body fusion device in skeletally mature patients
with degenerative disc disease (DDD - defined by discogenic
back pain with degeneration of the disc confirmed by patient
history and radiographic studies) at one or two contiguous
levels of the lumbar spine (L2-S1). Additionally, the
Catalyft™ LS Expandable Interbody System can be used with
patients diagnosed with multilevel degenerative scoliosis and
sagittal deformities as an adjunct to fusion. When used in
patients as an adjunct to fusion in patients diagnosed with
multilevel degenerative scoliosis and sagittal deformity
conditions, additional supplemental fixation (e.g. posterior
fixation) must be used. These patients should be skeletally
mature and have undergone 6 months of non-operative
treatment prior to surgery. Implants are used to facilitate fusion
in the lumbar spine using autogenous bone graft and/or
allograft bone graft comprised of cancellous and/or
corticocancellous bone, and/or demineralized allograft bone
with bone marrow aspirate.
These implants may be implanted via a variety of open or
minimally invasive anterior or oblique approach.
The Catalyft™ LS Expandable Interbody System device may
be used as a stand-alone device or in conjunction with
supplemental fixation. When used as a stand-alone device, the
Catalyft™ LS Expandable Interbody System device is
intended to be used with 4 titanium alloy screws. If the
physician chooses to use less than 4 or none of the provided
screws, additional supplemental fixation in the lumbar spine
must be used to augment stability. Implants with lordosis
angles greater than 20° are intended to be used with 4 screws
and supplemental fixation. |
| Comparison of
Technological
Characteristics with
the Predicate Devices | The subject device has the same or similar fundamental scientific
technology, indications for use, design, material, and levels of
attachment as the predicate devices. The subject device and
predicates are intended for stabilization use and to promote bone
fusion during the normal healing process following surgical
correction of disorders of the spine.
The subject interbody implant has an identical expansion
mechanism and size range as that of the primary predicate. |
| | The only difference between the subject device and the primary
predicate device is that the CatalyftTM LS nanoLOCKTM interbody
has Titan nanoLOCKTM Surface Technology. |
| Performance Data | The subject CatalyftTM LS nanoLOCKTM implants underwent the
following verification tests:
Static and Dynamic Compression per ASTM F2077-18 Static and Dynamic Compression Shear per ASTM F2077-
18 Subsidence per ASTM F2267-04(2018) Expulsion testing Wear Debris per ASTM F1877 (2016) MRI Safety Evaluation per ASTM 2503-20, ASTM
F2182-19e, ASTM 2052-21, F2213-17, F2219-07 |
| Conclusion | Based on the supporting evidence provided, Medtronic believes the
subject devices are substantially equivalent to the below predicates.
Predicate 1 (Primary Predicate): CatalyftTM LS Expandable
Interbody System (K212653, S.E. 11/19/2021)
Predicate 2: Anteralign LSTM Interbody System with Titan
nanoLOCKTM Surface Technology (K214010, S.E. 04/12/2022)
Predicate 3: CrescentTM PEEK (K094025, S.E. 04/26/2010;
K133216, S.E. 11/22/2013; K171031, S.E. 07/06/2017)
Predicate 4: ClydesdaleTM Spinal System (K100175, S.E.
06/02/2010; K132897, S.E. 12/11/2013; K133577, 09/26/2014)
Predicate 5: ElevateTM Spinal System (K142559, S.E. 06/09/2015) |
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