(286 days)
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML components.
Yes
The device is described as "Lancer Pedicle Screw System" which is an implantable system used for spinal fusion to treat instabilities or deformities, explicitly stating its role "as an adjunct to fusion". This indicates its direct therapeutic intervention for a medical condition.
No.
The document describes the Lancer Pedicle Screw System as an implantable device used for immobilization and fusion of spinal segments, not a device used to diagnose medical conditions.
No
The device description explicitly states it is comprised of polyaxial pedicle screws, rods, and crosslinks, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Lancer Pedicle Screw System is a surgical implant used to stabilize the spine. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes based on in vitro analysis.
The Lancer Pedicle Screw System is a surgical implant/device used for spinal fusion and stabilization.
N/A
Intended Use / Indications for Use
The Lancer Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Lancer Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-51 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Product codes
MNH, MNI
Device Description
The Lancer Pedicle Screw System is comprised of polyaxial pedicle screws, rods and crosslinks. The system consists of a variety of color coded top loading pedicle screws. The rods are Ø5.5mm and are available in straight and pre-lordosed (curved) configurations. The cross linkage assemblies fit over the rods to supply torsional stability to the construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine (L3 to sacrum), L5-S1 vertebrae
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
Non-clinical Test Summary: The following tests were conducted per ASTM F1717:
- Static compression bending
- Static torsion
- Dynamic compression bending
Clinical Test Summary: No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary for the Lancer Pedicle Screw System
DEC 1 5 2011
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Lancer Pedicle Screw System.
Date Prepared: March 1, 2011
| Submitter: | Contact Person: |
|---|---|
| Spinal Solutions LLC | J.D. Webb |
| 26157 Jefferson Avenue | The OrthoMedix Group, Inc. |
| Murrieta, CA 92562 | 1001 Oakwood Blvd |
| (951) 304-9001 | Round Rock, TX 78681 |
| Telephone: 512-388-0199 |
- Trade name: Lancer Pedicle Screw System orthosis, pedicle screw system Common Name: Classification Name: pedicle screw spinal system 21 CFR Sec. 888.3070 MNH MNI Class II
3. Predicate or legally marketed devices which are substantially equivalent:
The Lancer Pedicle Screw System is a modification of the Orthopedic Alliance Spine System (K033826). Other predicate devices include: KRD-1™ - K092420 (SpineFrontier)
4. Description of the device:
The Lancer Pedicle Screw System is comprised of polyaxial pedicle screws, rods and crosslinks. The system consists of a variety of color coded top loading pedicle screws. The rods are Ø5.5mm and are available in straight and pre-lordosed (curved) configurations. The cross linkage assemblies fit over the rods to supply torsional stability to the construct.
Purpose of 510(k):
The purpose of this 510(k) is to modifications to the Orthopedic Alliance Spine System. These changes include, changing the geometry of the pedicle screw head, add pedicle screw diameters, screw lengths, rod diameter, pre-bent rods, and rod lengths.
Materials:
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
Function:
The Lancer Pedicle Screw System is a pedicle screw system intended to provide immobilization and the stabilization of spinal segments until fusion takes place.
5. Substantial equivalence claimed to predicate devices
Lancer Pedicle Screw System is substantially equivalent to the Orthopedic Alliance Spine System and the KRD-1™ in terms of intended use, design, and materials used. The table below compares the features and characteristics of the Lancer Pedicle Screw System to these predicate devices.
1
| Device
Name | Lancer Pedicle
Screw System | Orthopedic
Alliance Spine
System | KRD-1TM |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Items | | | |
| Sponsor | Spinal Solutions | Orthopedic Alliance | SpineFrontier |
| 510(k) Number | N/A | K033826 | K092420 |
| Device
Classification
Name | orthosis, spinal
pedicle fixation per
MNI 888.3070
orthosis,
spondylolisthesis
spinal fixation per
MNH 888.3070 | orthosis, spinal
pedicle fixation per
MNI 888.3070
orthosis,
spondylolisthesis
spinal fixation per
MNH 888.3070 | orthosis, spinal
pedicle fixation per
MNI 888.3070
orthosis,
spondylolisthesis
spinal fixation per
MNH 888.3070 |
| Product Code | MNI, MNH | MNI, MNH | MNI, MNH |
| Class | Class II per 21 CFR
888.3070 | Class II per 21 CFR
888.3070 | Class II per 21 CFR
888.3070 |
| Straight rods | Yes | Yes | Yes |
| Pre-bent rods | Yes | No | Yes |
| Rod material | Ti-6Al-4V per ASTM
F136 | CP titanium per
ASTM F67 | Ti-6Al-4V per ASTM
F136 |
| Screw loading | Tulip top loading | Tulip top loading | Tulip top loading |
| Screw material | Titanium alloy per
ASTM F136 | Titanium alloy per
ASTM F136 | Titanium alloy per
ASTM F136 |
| Crosslinks -
length | Yes | Yes | Yes |
The following devices were used as predicate devices for strength comparison only:
6. Intended Use:
The Lancer Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Lancer Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-51 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
2
7. Non-clinical Test Summary:
The following tests were conducted per ASTM F1717:
- Static compression bending .
- . Static torsion
- Dynamic compression bending .
Clinical Test Summary 8.
No clinical studies were performed
9. Conclusions Nonclinical and Clinical
The Lancer Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and strength.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 15 2011
Spinal Solutions LLC % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K110633
Trade/Device Name: Lancer Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 13, 2011 Received: November 18, 2011
Dear Mr. Webb:
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. 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
4
Page 2 - Mr. J.D. Webb
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 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/ReportalProblem/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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erind Keith
Mark N. Melkerson 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): K110633
Device Name:
Indications for Use:
The Lancer Pedicle Screw System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Lancer Pedicle Screw System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K110633 510(k) Number_