(21 days)
Not Found
No
The description focuses on the material, shape, and dimensions of a spinal implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device replaces a removed vertebral body due to tumor or trauma/fracture, which serves a therapeutic purpose by restoring structural integrity and function.
No
This device is a spinal implant intended to replace a vertebral body that has been resected or excised. It is a physical implant, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made of PEEK and Titanium alloy, intended for surgical implantation. It is a hardware device, not software.
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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- SEMIALTM Spinal Implant Function: The SEMIALTM Spinal Implant is a physical device that is surgically implanted inside the body to replace a vertebral body. It is a structural implant, not a diagnostic tool that analyzes biological samples.
The provided text clearly describes a surgical implant used for structural support in the spine, not a device for in vitro testing.
N/A
Intended Use / Indications for Use
The SEMIALTM Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The SEMIALTM is intended to be implanted singularly.
The supplemental internal fixation systems that may be used with the SEMIALTM Spinal Implant are the same as the Curved PEEK Tetris Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The SEMIALTM Spinal implant is a hollow, semi-cylindrical form, slightly curved frame with tapered edges. The upper and lower aspects of the implant are open and the walls feature spikes which assist in the positive anchorage and seating of the implant between the superior and inferior vertebral bodies.
The frame is forged from PEEK (PEEK-OPTIMATM LT1), which is radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker pins so the device can be located within the body. The marker pins meet ASTM F-136 and ISO 5832/3.
The SEMIALTM Spinal Implant is available in a variety of sizes ranging in height from 9 mm to 49 mm with a enrolling diameter of either 43mm or 38mm and either a 2.5° or a 5.2° angle. A list of SEMIALTM sizes and model numbers maybe found in Appendix A. The provision of varying heights, together with a wedge shaped option, to allow better lordosis control, enables the surgeon to choose the size suited to the individual pathology and anatomical condition. The SEMIALTM may be implanted individually.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (from T1 to L5)
Indicated Patient Age Range
Not Found
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)
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
510(k) Summary
| Submitter: | SIGNUS Medizintechnik GmbH
Brentanostrasse 9
D-63755 Alzenau
Germany |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy L. Gray, RN, BS RAC
Principal Consultant
Alquest, Inc.
Phone: (763) 588-9873 Fax: (763) 287-3836 |
| Date Prepared: | June 17, 2004 |
| Trade Name: | SEMIALTM |
| Classification
Name and No: | 21 CFR 888.3060 |
| Product Code: | MQP |
| Predicate Device | Curved PEEK Tetris™ cleared under K041888 on 10-Aug-2004. |
| Device Description: | The SEMIALTM Spinal implant is a hollow, semi-cylindrical form,
slightly curved frame with tapered edges. The upper and lower aspects
of the implant are open and the walls feature spikes which assist in the
positive anchorage and seating of the implant between the superior and
inferior vertebral bodies.
The frame is forged from PEEK (PEEK-OPTIMATM LT1), which is
radiolucent, and incorporates small Titanium alloy (TiAl6V4) marker
pins so the device can be located within the body. The marker pins
meet ASTM F-136 and ISO 5832/3.
The SEMIALTM Spinal Implant is available in a variety of sizes ranging
in height from 9 mm to 49 mm with a enrolling diameter of either
43mm or 38mm and either a 2.5° or a 5.2° angle. A list of SEMIALTM
sizes and model numbers maybe found in Appendix A. The provision
of varying heights, together with a wedge shaped option, to allow better
lordosis control, enables the surgeon to choose the size suited to the
individual pathology and anatomical condition. The SEMIALTM may be
implanted individually. |
| Intended Use: | The SEMIALTM Spinal Implant is indicated for use to replace a vertebral
body that has been resected or excised due to tumor or trauma/fracture.
The device is intended for use as a vertebral body replacement in the
thoracolumbar spine (from T1 to L5) and is intended for use with
supplemental internal fixation.
The SEMIALTM is intended to be implanted singularly.
The supplemental internal fixation systems that may be used with the
SEMIALTM Spinal Implant are the same as the Curved PEEK Tetris
Spinal Implant and include, but are not limited to, DePuy AcroMed |
| Statement of
Technological
Comparison | titanium plate or rod systems (Kaneda SR, University Plate, M2,
ISOLA, VSP, Moss, TiMX, and Profile).
The subject device have the following similarities:
The same indication for use; The same operating principle; The same basic design; The same materials; Implanted using the same surgical techniques and equipment; Used in conjunction with the same types of supplemental internal fixation systems; The same manufacturing environment; The same sterilization process; and The same packaging configurations. In summary, the SEMIALTM, as described in this submission is, in the
opinion of Signus GmbH, substantially equivalent to the predicate
device. |
| Conclusion: | The SEMIALTM as modified in this submission, is substantially
equivalent to the predicate device, Curved PEEK TETRISTM cleared
under K041888. This conclusion is based upon the similarities of the
devices in terms of functional design, indication for use, principles of
operation, materials, and performance characteristics. |
pany
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05/65/1
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SIGNUS Medizintechnik GmbH C/o Ms. Tracy L. Gray Principal Consultant Alquest, Inc. 4050 Olson Memorial Hwy Suite 350 Minneapolis, Minnesota 55422
Re: K051659
Trade/Device Name: SEMIALTM Spinal Implant Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 17, 2005 Received: June 24, 2005
Dear Ms. Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications relerenced above and nave decembedly marketed predicate devices marketed in interstate for use statuu in the elefosure) to regard and the Medical Device Americal period for to commence prior to May 20, 1976, the excordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA devices that have been recuire approval of a premarket approval application (PMA). alle Costicule 71ct (71ct) that the not requence of the general controls provisions of the Act. The I va may, mereloro, manot of the Act include requirements for annual registration, listing of general controls provisions of use tice, labeling, and prohibitions against misbranding and adulteration.
JUL 1 3 2005
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (600 a0070) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation of t may be subject to back access as a segulations, 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 I Toast be advised that I Drivice and sever device complies with other requirements of the Act that i Dri has made a and regulations administered by other Federal agencies. You must of any I catal suatures and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (21 CFR Part 820); and If applicable, the electronic form in the quality by wome (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms. Tracy L. Gray
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and w you to ocgin mailioning your device of your device to a legally prematication. The PDF miaing of castification 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 If you desire specific advice for your accil 2011-01-0120. Also, please note the regulation entitled, Colliact the Office of Computers in (21 the Part 807.97). You may obtain Misblanding by reference to premainterial in the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours
Hypt Rudu
Miriam Roure, Ph.D.
m Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Page
510(k) Number (if known): K051651
. . . . .
SEMIAL™ Spinal Implant Device Name:
$
Indications for Use:
The SEMIAL™ Spinal Implant is indicated for use to replace a vertebral body that has been The SEMITAL - Spinal mipum or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. The SEMIAL™ is intended to be implanted singularly.
The internal fixation systems that may be used include, but are not limited to, DePuy AcroMed r the meental manon of of the may of the many Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile.)
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Acres of the many of the commended to be and the contribution of the | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | STATISTICS CONSULT OF CHARGE CONSULTION CONSULTION OF CHARGE | ||
|---|---|---|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
Prescription Use
(Per 21 CFR 801.109)
Or
Over-the-Counter Use -----------------------------------------------------------------------------
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
page 1 of 1
510(k) Number K051659
SIGNUS GMBH
SEMIAL™ Special 510(k)