(196 days)
Not Found
No
The description focuses on the material, design, and mechanical properties of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a partial vertebral body replacement intended to restore height and achieve decompression due to tumor or trauma/fracture, which directly treats a medical condition.
No
This device is a vertebral body replacement implant used for surgical intervention (restoring height, decompressing spinal cord), not for diagnosing conditions.
No
The device description explicitly states that the MC+ vertebral implants are comprised of physical components fabricated from PEEK and Tantalum wire markers, and comes with optional titanium alloy anchoring clips. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a diseased vertebral body due to tumor or trauma/fracture. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a physical implant made of PEEK and Tantalum, designed to be surgically placed in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectomy) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.
Product codes (comma separated list FDA assigned to the subject device)
MQP
Device Description
The MC+ vertebral implants consist of a series of square and rectangular D-shaped implants. The device is used in pairs as a partial vertebral body replacement in the thoracolumbar spine (from T1 to LS). The device is offered in seven different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy.
The LDR Spine USA. MC+ is comprised of a variety of components fabricated and manufactured from PolyEtherEtherKetone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The upper surface of the implant is arched in the anterior/posterior direction for increased stability. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes with optional anchoring clips made of titanium alloy.
Materials: all implants are made from implant grade PolyEtherKetone polymer (PEEK) with tantalum alloy position markers and titanium alloy as indicated in the table below:
PEEK Optima LT, USP Class VI ASTM F-2026, ISO 10993
Tantalum, ASTM F-560, ISO 5832-3
Titanium, ASTM F-136,92, ISO 5832-3
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)
Testing Summary. Fatigue and static testing is comples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device.
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.
K042268, K043206, K032064, K033109
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 | LDR Spine USA |
|---|---|
| Premarket Notification, Section 510(k) | JUNE 13, 2005 |
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
| 1. | Device Name: | ||
|---|---|---|---|
| Trade Name: | MC+ Partial VBR | JUN 3 0 2005 | |
| Common Name(s): | Vertebral Body Replacement | ||
| Classification Name(s): | Vertebral Body Replacement (MQP) | ||
| 2. | Establishment Name & Registration Number: |
LDR Spine USA Name: Number: 3004903783
3. Classification(s):
Sec. 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 eve-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.
| Device Class: | Class II for the requested indications |
|---|---|
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Product Code(s): | MQP |
4. Equivalent Predicate Device:
LDR Spine USA believes that the MC+ is substantially equivalent to the following:
K042268 - EBI CAS Spine Spacer System K043206 - Pioneer Vertebral Spacer K032064 – CPOD / LPOD VBR System K033109 - Ellys and Aurys VBR
Equivalence can be seen in the design, material composition, surgical technique and intended use.
5. Device Description:
The MC+ vertebral implants consist of a series of square and rectangular D-shaped implants. The device is used in pairs as a partial vertebral body replacement in the thoracolumbar spine (from T1 to LS). The device is offered in seven different configurations to better approximate the anatomical variation observed in different vertebral levels and/or patient anatomy.
The LDR Spine USA. MC+ is comprised of a variety of components fabricated and manufactured from PolyEtherEtherKetone (PEEK) as described by ASTM F-2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.
1
The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. The upper surface of the implant is arched in the anterior/posterior direction for increased stability. Tantalum wire markers (ASTM F-560) are inserted into components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively. The device comes with optional anchoring clips made of titanium alloy.
Materials: all implants are made from implant grade PolyEtherKetone polymer (PEEK) with tantalum alloy position markers and titanium alloy as indicated in the table below:
| PEEK
Optima LT | USP Class VI
ASTM F-2026 | ISO 10993 |
|-------------------|-----------------------------|------------|
| Tantalum | ASTM F-560 | ISO 5832-3 |
| Titanium | ASTM F-136,92 | ISO 5832-3 |
Indications for Use. The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectorny) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.
Testing Summary. Fatigue and static testing is comples were tested according to accepted engineering and scientific principals. Test results demonstrate that the system can be expected to perform in a manner equivalent to the comparison device.
Applicant Name & Address: 6.
LDR Spine USA
4030 W. Braker Ln., Ste. 360 Austin, TX 78759 Office: (512) 344-3333 (512) 344-3350 Fax:
7. Company Contact:
Mr. Edward E. Newton Dir. Reg. and Clinical Affairs LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX 78759 Office: (512) 344-3316 Fax: (512) 344-3350
8. Submission Correspondent:
Mr. Brian Burkinshaw Dir. Innovation & Technology Solutions LDR Spine USA 4030 W. Braker Ln., Ste. 360 Austin, TX 78759 Office: (512) 344-3304 (512) 344-3350 Fax:
9. Performance Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, LDR Spine, USA Standard Operating Procedures, vendor & process certification and
2
qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 13485 series quality regulations.
LDR Spine USA also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.
Storage, Packaging & Sterilization Information: 10.
The implantable portions of the MC+ are supplied "STERILE". The sterilization process is radiation and the selected protocol has been validated. The minimum Sterility Assurance Level (SAL) of at least 10-6.
The instruments are supplied non-sterile and must be sterilized prior to use. The recommended sterilization process for the instruments is high temperature steam autoclave sterilization. The referenced sterilization cycle produces a Sterility Assurance Level (SAL) of at least 10°
The validated cycle is:
Method: Steam Cycle: Gravity 270°F (134°C) Temperature: Exposure Time: 18 minutes
All packages containing implants or instruments should be intact upon receipt. Damaged packaging may indicate the presence of unsafe product. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the instruments must be placed into use following cleaning, sterilization and accepted surgical sterile technique.
Summary Comparison Table: 11.
Feature Comparison Table:
| FEATURE | MC+ | CAS Spine
Spacer
System | Pioneer
Vertebral
Spacer | CPOD /
LPOD VBR
System | Ellys and
Aurys VBR | SE? |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------|------------------------------|------------------------|-----|
| Indications for
Use: | The MC+ is indicated for use
for partial replacement (i.e.:
partial vertebrectomy) of a
diseased vertebral body that
has been resected or excised
due to tumor or
trauma/fracture in order to
achieve anterior
decompression of the spinal
chord and neural tissues, and
to restore the height of a
collapsed vertebral body. The
components are intended for
use in pairs for use as a
partial vertebral body
replacement in the
thoracolumbar spine (from
T1 to L5) and are intended
for use with supplemental
internal fixation such as the
Easyspine System to properly
utilize this system. | Same | Same | Same | Same | YES |
| Design: | Cage | Cage | Cage | Cage | Cage | YES |
| Sterile: | Yes | Yes | Yes | Yes | Yes | YES |
3
:
| Material: | PEEK w/ tantalum markers | Titanium | Peek | Titanium | PEEK w/
titanium
markers | YES |
|------------------------|-------------------------------------------------------------------------|----------|-----------------------------------|--------------|--------------------------------|-----|
| Instruments: | Specialized instruments
required. Reusable. Autoclave
before use. | Same | Same | Same | Same | YES |
| Bone Graft: | Required | Same | Same | Same | Same | YES |
| Secondary
Fixation: | Required | Same | Same | Same | Same | YES |
| How used: | Pairs | Singly | Singly | Pairs | Singly and
Pairs | YES |
| K Number: | K043479 | K042268 | K043206 | K032064 | K033109 | YES |
| Manufacturer: | LDR Spine USA | EBI | Pioneer
Surgical
Technology | Theken Spine | Scient'x | YES |
| Product Code: | MOP | MOP | MOP | MOP | MOP | YES |
.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2005
Mr. Brian Burkinshaw Director Technology Solutions LDR Spine USA Incorporated 4030 West Braker Lane,Suite 360 Austin, Texas 78759
Re: K043479
Trade/Device Name: MC+ Partial Vertebral Body Replacement (PVBR) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 12, 2005 Received: June 16, 2005
Dear Mr. Burkinshaw:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becaren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars and the Medical Device Amendments, or to commerce prices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do noos mat have over that do not require approval of a premarket approval application (PMA). and Cosmotion Free (110) that the device, subject to the general controls provisions of the Act. The r out may, aterers, inians 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 If your device 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drives Interves and regulations administered by other Federal agencies. You must or any I catal statures 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 Of It Fart 807), as except (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.
5
Page 2 – Mr. Brian Burkinshaw
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manxeant your antial equivalence of your everyte your devi premarket notification. THC PDF miding of backand experience 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 don't and the carres and the regulation entitled, and colliation of Computible at (2 + + ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = " Misoranding by release to promantee no illities under the Act from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or Manufacturers, International and Consanter Prosisions of the markets http://www.fda.html.
Sincerely yours,
Stypt Rurda
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Kodzu79
Page 1 of 1
510(k) Number: K043479
MC+ Partial Vertebral Body Replacement (PVBR) Device Name(s):
Indications for Use:
The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectomy) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Stret Ruvdr
Division Sign-Off
Division of General, Restorative and Neurological Devices
(Optional format 1-2-96)
510(k) Number K043479
Page 6 of 16