(903 days)
No
The device description focuses on mechanical components for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is intended for "immobilization and stabilization of the spine as an adjunct to fusion," indicating a direct therapeutic action to address various spinal conditions.
No
The Ti-TaMED Spinal System is described as an implantable device (rods, hooks, screws, connectors) used for immobilization and stabilization of the spine as an adjunct to fusion. Its function is to physically support the spine, not to detect, diagnose, or monitor a medical condition.
No
The device description explicitly details physical components like rods, hooks, screws, and connectors made of Titanium, which are hardware implants for spinal surgery. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Ti-TaMED Spinal System is described as a system of implants (rods, hooks, screws, etc.) used for the physical immobilization and stabilization of the spine during fusion surgery.
- Intended Use: The intended use clearly states it's for "immobilization and stabilization of the spine as an adjunct to fusion." This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used in vivo (within the body) to provide structural support, not to diagnose a condition by analyzing a sample in vitro (outside the body).
N/A
Intended Use / Indications for Use
The Ti-TaMED Spinal System is intended for immobilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and nonpedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Product codes
NKB, MNI, MNH, KWQ
Device Description
The Ti-TaMED Spinal System consists of a variety of rods, hooks, screws, cross connectors and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The System consists of four types of screws all manufactured out of Titanium (6A 1-4V ELI).
-
- Poly Axial Screws: These screws have a poly axial articulation that allows angulations of the head in all directions, but once the cap or grub screw and ring are tightened the position becomes locked.
Dimensions / sizes:
- Poly Axial Screws: These screws have a poly axial articulation that allows angulations of the head in all directions, but once the cap or grub screw and ring are tightened the position becomes locked.
- 5 mm diameter (Ø)(30mm lengths to 45 mm's)
- 6 mm Ø (30 mm to 50 mm)
- 7 mm Ø (30 mm to 50 mm)
-
- Rigid screws:
Dimensions/sizes:
- Rigid screws:
- 5 mm Ø (35 mm to 45 mm)
- 6 mm Ø (35 mm to 50 mm)
- 7 mm Ø (30 mm to 50 mm)
- 8 mm Ø (40 mm to 55 mm)
The Ti-TaMED Spinal system consists of two different types of rods:
Round both ends
- 5.5 mm Ø (30 mm to 1000 mm) .
Round and hexagonal ends
- 5.5 mm Ø (30 mm to 1000 mm) .
The Ti-TaMED Spinal system also consists of the following:
Cross Connector:
The Cross Connector is a device that links 2 vertical Ti-TaMED Connecting Rods to each other, thereby fulfilling the purpose of increasing torsional stiffness of a construct. The design includes the ability to accommodate non perpendicular connections between the Cross Connector and the Connecting Rods.
A complete Cross Connector is a unit comprising 2 each of the following: Body, Cap, Screw, Nut and Rod.
Dimensions / sizes:
- Only one size exists: the diameter of the cap is 14mm and the length of Rods are 60mm to 90mm
Hooks
-
- Pedicle Std. Straight 6 types:
-
- Laminar small straight
-
- Laminar large straight
-
- Laminar small angled
-
- Laminar left offset
-
- Laminar right offset
- grub screw and ring one size
Screw caps
- 1 type of cap (M10X1 thread) is used on all screws. 1 type of grub screw and ring is used on all screws.
The Ti-TaMED screws and rods may be used posteriorly or anteriorly to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or lumbar spine. The Ti-TaMED spinal implant components can be rigidly locked into a variety of configurations, with each case being tailor made for the individual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, sacral spine, L5-S1 vertebra
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Moss Miami Spinal System - DePuy Acromed, Inc. K022623, Polaris 5.5 – Biomet Spine. K081952
Reference Device(s)
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Image /page/0/Picture/0 description: The image shows the logo for Ti-TA MED (PTY) LTD, a manufacturer of quality surgical implants. The logo features a stylized "Ti" with a medical symbol incorporated into the "T". Below the logo is the text "MANUFACTURERS OF QUALITY SURGICAL IMPLANTS".
54 AUCKLAND ST, PAARDEN EILAND, 7405 PO BOX 232, PAARDEN EILAND, 7420 SOUTH AFRICA
TEL: +27 (0)21-510 8382 FAX: +27 (0)21-510 0745
EMAIL: titamed@mweb.co.za WEBSITE: www.ti-tamed.com
KC070385
510((k) Summary:
Contact: Sandi Ashbury Company Correspondent
29 July 2009
JUL 3 1 2009
| Trade name: | Ti-TaMED Spinal System |
|---|---|
| Common Name: | Spinal Fixation Device |
| Classification Name: | Spinal Interlaminal Fixation Orthosis, Spondylolisthesis Spinal fixation Device System, Pedicle Screw Fixation System. |
| Equivalent device: | Moss Miami Spinal System - DePuy Acromed, Inc. K022623 |
| Polaris 5.5 – Biomet Spine. K081952 |
Product Description:
The Ti-TaMED Spinal System consists of a variety of rods, hooks, screws, cross connectors and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.
The System consists of four types of screws all manufactured out of Titanium (6A 1-4V ELI).
-
- Poly Axial Screws: These screws have a poly axial articulation that allows angulations of the head in all directions, but once the cap or grub screw and ring are tightened the position becomes locked.
Dimensions / sizes:
- Poly Axial Screws: These screws have a poly axial articulation that allows angulations of the head in all directions, but once the cap or grub screw and ring are tightened the position becomes locked.
-
. 5 mm diameter (Ø)(30mm lengths to 45 mm's)
-
. 6 mm Ø (30 mm to 50 mm)
-
트 7 mm Ø (30 mm to 50 mm)
-
- Rigid screws:
Dimensions/sizes:
- . 5 mm Ø (35 mm to 45 mm)
- 6 mm Ø (35 mm to 50 mm)
- 7 mm Ø (30 mm to 50 mm)
- 8 mm Ø (40 mm to 55 mm)
Image /page/0/Picture/23 description: The image shows a stylized letter "T" with a caduceus symbol intertwined within its form. The caduceus, featuring a staff with two snakes winding around it, is centrally positioned within the "T". The letter "T" itself has a blocky, somewhat pixelated appearance, with horizontal bars at the top and bottom and a vertical bar in the middle.
QUALITY MANAGEMENT SYSTEM
Certified by Lloyds against ISO 9001, ISO 13485 and Annex II of Directive 93/42/EEC
Image /page/0/Picture/26 description: The image contains two logos. The logo on the left is a circular logo with the letter "R" in the center. The text "LLOYD'S REGISTER QUALITY ASSURANCE - ISO9001" is written around the circle. The logo on the right has a crown on top of a check mark. The text "UKAS QUALITY MANAGEMENT" is written below the check mark, and the number "001" is at the bottom.
1
The Ti-TaMED Spinal system consists of two different types of rods:
Round both ends
- 5.5 mm Ø (30 mm to 1000 mm) .
Round and hexagonal ends
- 5.5 mm Ø (30 mm to 1000 mm) .
The Ti-TaMED Spinal system also consists of the following:
Cross Connector:
The Cross Connector is a device that links 2 vertical Ti-TaMED Connecting Rods to each other, thereby fulfilling the purpose of increasing torsional stiffness of a construct. The design includes the ability to accommodate non perpendicular connections between the Cross Connector and the Connecting Rods.
A complete Cross Connector is a unit comprising 2 each of the following: Body, Cap, Screw, Nut and Rod.
Dimensions / sizes:
- Only one size exists: the diameter of the cap is 14mm and the length of Rods are 60mm to 90mm
Hooks
-
- Pedicle Std. Straight 6 types:
-
- Laminar small straight
-
- Laminar large straight
-
- Laminar small angled
-
- Laminar left offset
-
- Laminar right offset
- grub screw and ring one size 트
Screw caps
- 1 type of cap (M10X1 thread) is used on all screws. 1 type of grub screw and ring is used on all screws.
The Ti-TaMED screws and rods may be used posteriorly or anteriorly to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic. lumbar and/or lumbar spine. The Ti-TaMED spinal implant components can be rigidly locked into a variety of configurations, with each case being tailor made for the individual.
Image /page/1/Picture/22 description: The image shows a symbol that appears to be a stylized version of the Rod of Asclepius, a traditional symbol associated with medicine and healthcare. The rod is depicted as a vertical staff with a snake coiled around it. At the top of the rod, there is a horizontal bar, giving the symbol a 'T' shape. The overall design is simple and monochromatic.
QUALITY MANAGEMENT SYSTEM
Certified by Lloyds against ISO 9001, ISO 13485 and Annex II of Directive 93/42/EEC
Image /page/1/Picture/24 description: The image contains two logos. The logo on the left is a circular logo with the letter R in the center. The text around the circle reads 'Lloyd's Register Quality Assurance ISO 9001'. The logo on the right is a rectangular logo with a crown and a checkmark above the text 'UKAS Quality Management 001'.
2
The Ti-TaMED hooks and cross connectors are intended for posterior only, where as all other components may be used anteriorly or posteriorly.
Indications for use:
The Ti-TaMED Spinal System is intended for immobilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and nonpedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, lordosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Image /page/2/Picture/3 description: The image shows a stylized symbol that resembles the letter 'T' intertwined with a caduceus, a symbol often associated with medicine. The caduceus features a staff with two snakes coiling around it. The 'T' shape is formed by horizontal bars at the top and bottom, connected by the staff of the caduceus, creating a unified design that blends typography with medical symbolism.
QUALITY MANAGEMENT SYSTEM
Certified by Lloyds against ISO 9001, ISO 13485 and Annex II of Di
Image /page/2/Picture/6 description: The image contains two logos. The logo on the left is a circular logo with the letter R in the center. The text around the circle reads "LLOYD'S REGISTER QUALITY ASSURANCE - ISO9001". The logo on the right is a UKAS Quality Management logo with a crown and a checkmark. The number 001 is at the bottom of the UKAS logo.
DIRECTOR: AR KATZ - REG NO. 2000/021595/07
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ti-TaMed (PTY) LTD % Ms. Sandra Mortimer 54 Auckland Street Paarden Eiland Cape Town. Western Cape South Africa 7405
JUL 3 1 2009
Re: K070385
Trade/Device Name: Ti-TaMED Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWQ Dated: April 30, 2009 Received: April 30, 2009
Dear Ms. Mortimer:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Sandra Mortimer
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ofabare Burns
Mark N. Melk rson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K070385
Device Name: Ti-TaMED Spinal System
Indications For Use:
The Ti-TaMED Spinal System is intended for immobilization and stabilization of the spine as an adjunct to fusion for use in anterior, anterolateral, or posterior non-cervical pedicle and non-pedicle fixation for spinal conditions in skeletally mature patients with significant mechanical instability or deformity requiring fusion of the thoracic, lumbar or sacral spine secondary to the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ez------ VEX7 for MKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KO40385 510(k) Number_