(65 days)
Not Found
No
The device description focuses on the physical components (screws, plates, washer, instruments) and their materials and dimensions. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for stabilization and buttressing of bone graft following anterior structural reconstruction for degenerative disc disease (DDD), which is a medical condition. This indicates a therapeutic purpose.
No
The device is described as an Anterior Lumbar Buttress System, which includes screws, plates, and a washer, intended for stabilization and buttressing of bone graft. Its function is to provide physical support and fixation, not to diagnose a condition.
No
The device description explicitly lists hardware components (screws, plates, washer, instruments) and their materials and dimensions. There is no mention of software as a component of this system.
Based on the provided information, 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 Description: The Anterior Lumbar Buttress System is a physical implantable device (screws, plates, washer) intended for surgical fixation in the spine.
- Intended Use: The intended use is for stabilization and buttressing of bone graft in the spine, a surgical procedure, not an in vitro test.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Anterior Lumbar Buttress System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Anterior Lumbar Buttress System includes titanium allov screws, buttress plates, and a washer. The screws will be offered in 5.5 and 6.5mm diameters and in six lengths, 18, 20, 22, 24, 25, and 26mm, for each diameter. The plates will be available in three sizes: 15 x 19, 15 x 20, and 15 x 21mm. The washer will be offered in a 15mm size to be compatible with the plates. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The Anterior Lumbar Buttress System also utilizes some instruments to assist in placement of the devices. These instruments include a plate inserter, hex driver, and an awl. The instruments will be fabricated from stainless steel, aluminum, and Radel. The product is supplied "NON-STERILE" 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
L1-S1 spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration.
Description of the test set, sample size, data source, and annotation protocol
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Anterior Lumbar Buttress System
510(K) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.
| Submitter Information: | SeaSpine, Inc.
Contact: Kirt Stephenson
6276 River Crest Drive, Suite E
Riverside, CA 92507-0754
Phone: 909-656-4850 Fax: 909-656-5530 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | The Regulatory Affairs Company
Contact: Diana Smith
727 Park Boulevard
San Diego, CA 92101
Phone: 619-251-9132 Fax: 619-696-9883 |
| Date Summary Prepared: | January 8, 2004 |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis
(Class II) - KWQ 888-3060 |
| Common/Usual Name: | Anterior Lumbar Buttress System |
| Device Trade Name: | Anterior Lumbar Buttress System |
The primary devices used for comparison in this summary are DePuy AcroMed™. Inc.'s BowTi Anterior Buttress Staple System (K021039) and Synthes' Synthes Titanium Locking Plate System (K970048).
-
- Intended Use: (The statements of intended use are identical.)
The intended use of the Anterior Lumbar Buttress System and associated components is substantially equivalent to the intended use of the predicate devices. The Anterior Lumbar Buttress System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- Intended Use: (The statements of intended use are identical.)
$$
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1
Anterior Lumbar Buttress System
2. Description:
The Anterior Lumbar Buttress System includes titanium allov screws, buttress plates, and a washer. The screws will be offered in 5.5 and 6.5mm diameters and in six lengths, 18, 20, 22, 24, 25, and 26mm, for each diameter. The plates will be available in three sizes: 15 x 19, 15 x 20, and 15 x 21mm. The washer will be offered in a 15mm size to be compatible with the plates. The product is supplied "NON-STERILE" and must be sterilized prior to use
The Anterior Lumbar Buttress System also utilizes some instruments to assist in placement of the devices. These instruments include a plate inserter, hex driver, and an awl. The instruments will be fabricated from stainless steel, aluminum, and Radel. The product is supplied "NON-STERILE" and must be sterilized prior to use.
3. Technological Characteristics:
The Anterior Lumbar Buttress System has substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section. entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.
4. Comparison Analysis:
The overall design of the Anterior Lumbar Buttress System is substantially equivalent to the predicate devices. See Table 1 below for a comparison of the Anterior Lumbar Buttress System and the predicate devices.
| Feature | Anterior Lumbar
Buttress System | Synthes Strimix
Locking Plate
System | BowTi Anterior
Buttress Staple
System | Substantially
Equivalent |
|------------------------|-----------------------------------------------------|--------------------------------------------|---------------------------------------------|-----------------------------|
| Intended Use | See Insert | Similar | Similar | Yes |
| Indications
for Use | See Insert | Same | Similar | Yes |
| Design | Buttress plate with
screw and locking
chamfer | Similar | Similar | Yes |
| Sizes | See prints | Similar | Similar | Yes |
| Material | Titanium | Same | Same | Yes |
| Sterile | Non-sterile | Same | Same | Yes |
| Mechanical
Strength | See test results | Similar | Similar | Yes |
Table 1: Summary of Design Comparison
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2
Anterior Lumbar Buttress System
-
A financial certification or disclosure statement or both, as required by part 54 (i) of this chapter:
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration. -
(i) For submission claiming substantial equivalence to a device which has been classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III Summary). The 510(K) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807,94.
A class III Certification and Summary is not needed for this submission as the products under consideration are class II.
- (k)_ A statement that the submitter believes, to the best of his or her knowledge. that all data and information submitted in the Premarket notification are truthful and accurate and that no material fact has been omitted.
A Premarket Notification Truthful and Accurate Statement is included on the following page.
Page 3 of 3
3
Image /page/3/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the border. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2004
Ms. Diana Smith The Regulatory Affairs Company 727 Park Boulevard San Diego, California 92101
Re: K040130
Trade/Device Name: Anterior Lumbar Buttress System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: January 8, 2004 Received: January 21, 2004
Dear Ms. Smith:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Diana Smith
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Mark N Milliman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): _KO40130
Device Name: Anterior Lumbar Buttress System
The Anterior Lumbar Buttress System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent intervertebral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of a discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Murle N. Milkerson
Division of Gener and Neurological Jevices
510(K) Number K040130
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use X
(Per 21 CFR § 801.109)
OR
Over-The-Counter-Use ---