(240 days)
No
The device description and performance studies focus on the mechanical properties of the spinal implant system, with no mention of AI or ML.
Yes
The device is intended to treat acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, providing immobilization and stabilization as an adjunct to fusion. This indicates a direct therapeutic effect on the patient's condition.
No
The device is described as a system for immobilization and stabilization of spinal segments, indicating its therapeutic rather than diagnostic function. It is used in the treatment of various spinal conditions, not for identifying or diagnosing them.
No
The device description explicitly states it is a "rod-hook-screw system" and mentions components made of titanium, stainless steel, and cobalt-chromium-molybdenum, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used within the body to treat structural issues.
- Device Description: The description details a "rod-hook-screw system" made of various metals, which are components of a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical implant used to treat a physical condition.
N/A
Intended Use / Indications for Use
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
The EXPED!UM PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from L1-S1 in skeletally mature patients.
Product codes
NKB, MNI, MNH, KWQ, KWP
Device Description
The EXPEDIUM® 4.5mm Spine System is a rod-hook-screw system. The EXPEDIUM 4.5mm Spine System proposed single and dual diameter rods are offered in titanium, stainless steel, and cobalt-chromiummolybdenum. They are available in various geometries and sizes to accommodate patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and sacral spine, noncervical
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
Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification. Specifically, static and dynamic compression testing as well as static torsion testing were performed.
Key Metrics
Not Found
Predicate Device(s)
K063772, K090230, K092473, K011182, K023804
Reference Device(s)
Not Found
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
| A. | Submitter Information | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 |
|----|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Daphney Germain-Kolawole
Regulatory Affairs Associate |
| | Voice: | (508) 880-8395 |
| | Fax: | (508) 828-3797 |
| | E-Mail: | dgermain@its.jnj.com |
| B. | Date Prepared | 2/25/2011 |
| C. | Device Class | Class III |
| D. | Device Name | |
| | Trade/Proprietary Name: | EXPEDIUM Spine System |
| | Common/Usual Name: | Pedicle Screw Spinal System |
| | Classification Name: | Spinal interlaminar fixation orthosis
per 21 CFR §888.3050
Spinal intervertebral body fixation orthosis
per 21 CFR §888.3060
Pedicle screw spinal fixation
per 21 CFR §888.3070 |
| | Classification Panel: | Orthopaedics |
| | FDA Panel Number: | 87 |
DePuy Spine, Inc., a Johnson & Johnson Company
Ps 1 of 3
1
E. Product Code(s)
NKB, MNI, MNH, KWQ , KWP
F. Predicate Device Name
Trade name: DePuy Spine EXPEDIUM® Spine System (K063772) DePuy Spine EXPEDIUM® Spine System (K090230) DePuy Spine EXPEDIUM® Spine System (K092473) DePuy Spine MOSS MIAMI Spine System (K011182) DePuy Spine MOSS MIAMI Spine System (K023804)
E. Device Description
The EXPEDIUM® 4.5mm Spine System is a rod-hook-screw system. The EXPEDIUM 4.5mm Spine System proposed single and dual diameter rods are offered in titanium, stainless steel, and cobalt-chromiummolybdenum. They are available in various geometries and sizes to accommodate patient anatomy.
F. Intended Use
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System metallic components are intended for noncervical pedicle fixation and nonpedicle fixation for fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The EXPED!UM PEEK rods are only indicated for fusion procedures for spinal stenosis with instability (no greater than Grade I spondylolisthesis) from L1-S1 in skeletally mature patients.
2
KIIOSSI
F. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The proposed modifications to the DePuy Spine EXPEDIUM® 4.5mm Spine System are identical to the predicate devices except that the dual diameter rods are offered in cobalt-chromium-molybdenum alloy and in additional sizes. Also, the labeling limitation indicating the minimum screw diameter size no longer applies and is removed from the instructions for use. The design, materials, and technology remain identical to the predicate systems.
G. Materials
Manufactured from ASTM F 1537 implant grade cobalt-chromiummolybdenum alloy, ASTM F 138 implant grade stainless steel, and ASTM F 136 implant grade titanium alloy.
H. Performance Data
Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification. Specifically, static and dynamic compression testing as well as static torsion testing were performed.
l. Conclusion
Both the Performance Testing and Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
DePuy Spine, Inc., a Johnson & Johnson Company
Ps 3 of 3
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus-like symbol in the center, consisting of three vertical lines with wavy bases, resembling a stylized representation of a staff with snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 6 2011
DePuy Spine, Inc. % Mr. Frank Jurczak Sr. Regulatory Affairs Associate 325 Paramount Drive Raynham, Masschusetts 02767
Re: K110551
Trade/Device Name: EXPEDIUM Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP, KWQ Dated: September 30, 2011 Received: October 03, 2011
Dear Mr. Jurczak:
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 not 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
4
Page 2 - Mr. Frank Jurczak
CFR Part 807): labeling (21 CFR Part 801): medical device 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/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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedi and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KIIOSSI
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: EXPEDIUM® Spine System
Indications For Use:
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Diysion Sign-Off Division of Surgical Orthopedic, and Restorative Devices
5 ' 0(k) Number_K 110551
DePuy Spine, Inc., a Johnson & Johnson Company