(69 days)
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM 5.5mm and 6.35mm Spine Systems.
The uses of the legally marketed EXPEDIUM 5.5mm and 6.35mm Spine System are as follows:
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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available VSP Spine System.
The uses of the legally marketed VSP Spine System are as follows:
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grade 3 and 4) at L5-S1, in skeletally mature patients, when autogeous bone graft is used, when affixed to the posterior lumbosacral spin, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available ISOLA 6.35mm Spine System.
The uses of the legally marketed ISOLA 6.35mm Spine System are as follows:
The ISOLA Spine Systems is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ISOLA Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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.
The ISOLA Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available MOSS Miami 6.35mm Spine System.
The uses of the legally marketed MOSS Miami 6.35mm Spine System are as follows:
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami 6.35mm Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Miami 6.35mm Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
The MOSS Miami 6.35mm Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 5.5mm and 6.35mm spinal rods of the EXPEDIUM Spine System.
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the VSP Spine System.
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the ISOLA Spine System.
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the MOSS Miami Spine System.
The provided text describes a Special 510(k) Submission for additions to the EXPEDIUM™ SFX Cross Connector System. This submission focuses on the mechanical performance and material compatibility of the device, rather than artificial intelligence or diagnostic algorithms. Therefore, many of the requested categories related to AI performance, expert consensus, and ground truth establishment are not applicable.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The acceptance criterion for the EXPEDIUM™ SFX Cross Connector System is that its performance, when transversely connecting two rods, must be equivalent or superior to the predicate devices. Specifically, it must minimize torsional forces on the construct, thereby reducing micromotion and the probability of construct shifting after placement. This is assessed through Performance data per ASTM F 1717.
Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Fidelity | Performance data per ASTM F 1717 showed equivalence to predicate devices (DePuy Motech MOSS MIAMI Spinal System (K933881) and SFX Snap-Fit Cross Connector System (K062196)). The device is designed to minimize torsional forces, reduce micromotion, and prevent construct shifting. | "Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification." (This implies the data met the standard, demonstrating equivalence to predicates in mechanical properties and function.) |
| Material | Manufactured from ASTM F 138 implant grade stainless steel. | "Manufactured from ASTM F 138 implant grade stainless steel." (This meets the material standard.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a numerical value within the provided text. The performance data is "per ASTM F 1717," which is a standard for in vitro mechanical testing of spinal implant constructs. The sample size would be determined by the requirements of this ASTM standard for various tests (e.g., static, fatigue, torsional).
- Data Provenance: The data is based on in vitro mechanical testing conducted according to ASTM F 1717. This is laboratory-based testing, not human-patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable as the study is a mechanical performance study of a medical device, not an AI or diagnostic imaging study that requires expert review for ground truth establishment.
4. Adjudication Method for the Test Set
This question is not applicable as the study is a mechanical performance study. Adjudication methods like 2+1 or 3+1 refer to human expert consensus, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance
This question is not applicable. This submission concerns the mechanical properties of a spinal implant, not an AI-assisted diagnostic or treatment system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
This question is not applicable. This is a device related to mechanical stability in spinal instrumentation, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering and material science standards, specifically ASTM F 1717, which dictates test methodologies and expected performance characteristics for spinal implant components. The "truth" is that the device must meet or exceed the mechanical performance characteristics of the predicate devices under standardized testing conditions.
8. The Sample Size for the Training Set
This question is not applicable as this is not an AI/machine learning study.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as this is not an AI/machine learning study.
{0}------------------------------------------------
. Special 510(k) Submission – Additions to EXPEDIUM™ SFX Cross Connector System
5. 510(K) SUMMARY – K070300
| 5.1. 510(k) Summary - EXPEDIUM 5.5mm / 6.35mm Spine Systems |
|---|
| ------------------------------------------------------------- |
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 | APR 10 2007 |
|---|---|---|
| Contact Person: | Christopher KlaczykRegulatory Affairs Project ManagerVoice: (508) 828-2852Fax: (508) 828-3797E-Mail: cklaczyk@dpyus.jnj.com | |
| Date Prepared: | January 30, 2007 | |
| Device Class: | Class III | |
| Classification Name: | Pedicle screw spinal fixation (§888.3070) | |
| Classification Panel: | Orthopedics | |
| FDA Panel Number: | 87 | |
| Product Code(s): | KWP, KWQ, MNH, MNI, NKB | |
| Proprietary Name: | EXPEDIUM SFX Cross Connector System | |
| Predicate Devices: | DePuy Motech MOSS MIAMI Spinal System (K933881),SFX Snap-Fit Cross Connector System (K062196) | |
| Device Description: | The EXPEDIUM SFX Cross Connector System is designedto transversely connect two rods used in spinalinstrumentation constructs. The connector minimizes thetorsional forces on the construct, thus reducing themicromotion and the probability of the construct shiftingafter placement. It is designed to accommodate the 5.5mmand 6.35mm spinal rods of the EXPEDIUM Spine System. | |
| Intended Use: | The EXPEDIUM SFX Cross Connector System is designedto transversely connect two rods used in spinalinstrumentation constructs. The EXPEDIUM SFX CrossConnector System devices are intended for use withcomponents of the commercially available EXPEDIUM5.5mm and 6.35mm Spine Systems. |
DePuy Spine, Inc., a Johnson & Johnson Company
:
:
:
Page 1 of 2
Page
{1}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
The uses of the legally marketed EXPEDIUM 5.5mm and 6.35mm Spine System are as follows:
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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
- Manufactured from ASTM F 138 implant grade stainless Materials: steel.
Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification.
2 of
DePuy Spine, Inc., a Johnson & Johnson Company
{2}------------------------------------------------
Special 510(k) Submission – Additions to EXPEDIUM™ SFX Cross Connector System
| 5.2. | 510(k) Summary – VSP 6.35mm Spine System |
|---|---|
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 |
| Contact Person: | Christopher KlaczykRegulatory Affairs Project ManagerVoice: (508) 828-2852Fax: (508) 828-3797E-Mail: cklaczyk@dpyus.jnj.com |
| Date Prepared: | January 30, 2007 |
| Device Class: | Class II |
| Classification Name: | Spinal interlaminar fixation orthosis, $§888.3050$Pedicle screw spinal fixation, $§888.3070$ |
| Classification Panel: Orthopedics | |
| FDA Panel Number: 87 | |
| Product Code(s): | KWP, MNH, MNI |
| Proprietary Name: | EXPEDIUM SFX Cross Connector System |
| Predicate Devices: | DePuy Motech MOSS MIAMI Spinal System (K933881),SFX Snap-Fit Cross Connector System (K062196) |
| Device Description: | The EXPEDIUM SFX Cross Connector System is designedto transversely connect two rods used in spinalinstrumentation constructs. The connector minimizes thetorsional forces on the construct, thus reducing themicromotion and the probability of the construct shiftingafter placement. It is designed to accommodate the6.35mm spinal rods of the VSP Spine System. |
| Intended Use: | The EXPEDIUM SFX Cross Connector System is designedto transversely connect two rods used in spinalinstrumentation constructs. The EXPEDIUM SFX CrossConnector System devices are intended for use withcomponents of the commercially available VSP 6.35mmSpine System. |
510(k) Summary - VSP 6 35mm Snine System 5.2.
DePuy Spine, Inc., a Johnson & Johnson Company
Page 5-3
of 7
{3}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
The uses of the legally marketed VSP 6.35mm Spine System are as follows:
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grade 3 and 4) at L5-S1, in skeletally mature patients, when autogeous bone graft is used, when affixed to the posterior lumbosacral spin, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
Manufactured from ASTM F 138 implant grade stainless Materials: steel.
Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification.
2 of 2
DePuy Spine, Inc., a Johnson & Johnson Company
{4}------------------------------------------------
070300
Special 510(k) Submission – Additions to EXPEDIUM™ SFX Cross Connector System
| 5.3. 510(k) Summary - ISOLA 6.35mm Spine System | |
|---|---|
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 |
| Contact Person: | Christopher KlaczykRegulatory Affairs Project ManagerVoice: (508) 828-2852Fax: (508) 828-3797E-Mail: cklaczyk@dpyus.jnj.com |
| Date Prepared: | January 30, 2007 |
| Device Class: | Class II |
| Classification Name: | Spinal interlaminar fixation orthosis, $§888.3050$Pedicle screw spinal fixation, $§888.3070$ |
| Classification Panel: | Orthopedics |
| FDA Panel Number: | 87 |
| Product Code(s): | KWP, MNH, MNI |
| Proprietary Name: | EXPEDIUM SFX Cross Connector System |
| Predicate Devices: | DePuy Motech MOSS MIAMI Spinal System (K933881),SFX Snap-Fit Cross Connector System (K062196) |
| Device Description: | The EXPEDIUM SFX Cross Connector System is designedto transversely connect two rods used in spinalinstrumentation constructs. The connector minimizes thetorsional forces on the construct, thus reducing themicromotion and the probability of the construct shiftingafter placement. It is designed to accommodate the6.35mm spinal rods of the ISOLA Spine System. |
| Intended Use: | The EXPEDIUM SFX Cross Connector System is designedto transversely connect two rods used in spinalinstrumentation constructs. The EXPEDIUM SFX CrossConnector System devices are intended for use withcomponents of the commercially available ISOLA 6.35mmSpine System. |
DePuy Spine, Inc., a Johnson & Johnson Company
.
- of 2
{5}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
The uses of the legally marketed ISOLA 6.35mm Spine System are as follows:
The ISOLA Spine Systems is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ISOLA Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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.
The ISOLA Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Materials: Manufactured from ASTM F 138 implant grade stainless steel.
- Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification.
7 of 2
DePuy Spine, Inc., a Johnson & Johnson Company
{6}------------------------------------------------
Special 510(k) Submission – Additions to EXPEDIUM™ SFX Cross Connector System
| 5.4. 510(k) Summary - MOSS Miami 6.35mm Spine System | |
|---|---|
| Submitter: | DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767 |
| Contact Person: | Christopher Klaczyk Regulatory Affairs Project Manager Voice: (508) 828-2852 Fax: (508) 828-3797 E-Mail: cklaczyk@dpyus.jnj.com |
| Date Prepared: | January 30, 2007 |
| Device Class: | Class II |
| Classification Name: | Spinal interlaminar fixation orthosis, $$888.3050$ Pedicle screw spinal fixation, $§888.3070$ |
| Classification Panel: | Orthopedics |
| FDA Panel Number: | 87 |
| Product Code(s): | KWP, MNH, MNI |
| Proprietary Name: | EXPEDIUM SFX Cross Connector System |
| Predicate Devices: | DePuy Motech MOSS MIAMI Spinal System (K933881), SFX Snap-Fit Cross Connector System (K062196) |
| Device Description: | The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The connector minimizes the torsional forces on the construct, thus reducing the micromotion and the probability of the construct shifting after placement. It is designed to accommodate the 6.35mm spinal rods of the MOSS Miami Spine System. |
| Intended Use: | The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available MOSS Miami 6.35mm Spine System. |
DePuy Spine, Inc., a Johnson & Johnson Company
pay 1 of 2
P
Page 5–7
{7}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
The uses of the legally marketed MOSS Miami 6.35mm Spine System are as follows:
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami 6.35mm Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Miami 6.35mm Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
The MOSS Miami 6.35mm Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.
Manufactured from ASTM F 138 implant grade stainless Materials: steel.
Performance Data: Performance data per ASTM F 1717 were submitted to characterize the subject EXPEDIUM™ Spine System components addressed in this notification.
s
2 of 2
DePuy Spine, Inc., a Johnson & Johnson Company
{8}------------------------------------------------
Public Health Service
Image /page/8/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Spine, Inc. % Mr. Christopher Klaczyk Regulatory Affairs Project Manager 325 Paramount Drive Raynham, Massachusetts 02767
APR 1 0 2007
Re: K070300 Trade/Device Name: EXPEDIUM™ SFX Cross Connector System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWP, KWQ Dated: March 9, 2007 Received: March 12, 2007
Dear Mr. Klaczyk:
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 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 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); 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.
{9}------------------------------------------------
Page 2 - Mr. Christopher Klaczyk
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your he FDA finding of substantial equivalence of your device to a legally premaince holicated wice results in a classification 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 contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely, yours,
Qarbaye Buchemo
to
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
{10}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
INDICATIONS FOR USE STATEMENT 4.
Indications for Use - EXPEDIUM™ 5.5mm / 6.35mm Spine Systems 4.1.
510(k) Number (if known):
Device Name: EXPEDIUM™ SFX Cross Connector System
Indications For Use:
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available EXPEDIUM 5.5mm and 6.35mm Spine Systems.
The uses of the legally marketed EXPEDIUM 5.5mm and 6.35mm Spine System are as follows:
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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Prescription Use (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Starbare buehim
Division Sign Division of Gener al. Restorative and Neurological De
Page 1 of
510(k) Number K070300
DePuy Spine, Inc., a Johnson & Johnson Company
Page 4-1
{11}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
Indications for Use - VSP® Spine System 4.2.
510(k) Number (if known):
Device Name: EXPEDIUM™ SFX Cross Connector System
Indications For Use:
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available VSP Spine System.
The uses of the legally marketed VSP Spine System are as follows:
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudoarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The VSP Spine System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grade 3 and 4) at L5-S1, in skeletally mature patients, when autogeous bone graft is used, when affixed to the posterior lumbosacral spin, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buellmo
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K070300
ge 1 of 1
DePuy Spine, Inc., a Johnson & Johnson Company
Page 4-2
{12}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
Indications for Use - ISOLA® 6.35mm Spine System 4.3.
510(k) Number (if known):
Device Name: EXPEDIUM™ SFX Cross Connector System
Indications For Use:
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available ISOLA 6.35mm Spine System.
The uses of the legally marketed ISOLA 6.35mm Spine System are as follows:
The ISOLA Spine Systems is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The ISOLA Spine Systems is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra 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.
The ISOLA Spine Systems is also a hook and sacral/iliac screw fixation system of the noncervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).
The ISOLA Spinal System when used with pedicle screws is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Prescription Use (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Oubare Brient
Division of General, Restorative. and Neurological Devices
Page 1 of 1
510(k) Number K070300
DePuy Spine, Inc., a Johnson & Johnson Company
{13}------------------------------------------------
Special 510(k) Submission - Additions to EXPEDIUM™ SFX Cross Connector System
Indications for Use - MOSS® Miami 6.35mm Spine System 4.4.
510(k) Number (if known):
Device Name: EXPEDIUM™ SFX Cross Connector System
Indications For Use:
The EXPEDIUM SFX Cross Connector System is designed to transversely connect two rods used in spinal instrumentation constructs. The EXPEDIUM SFX Cross Connector System devices are intended for use with components of the commercially available MOSS Miami 6.35mm Spine System.
The uses of the legally marketed MOSS Miami 6.35mm Spine System are as follows:
When used as a posterior, noncervical hook, and/or sacral/iliac screw fixation system, or as an anterior, thoracic/lumbar screw fixation system, the MOSS Miami 6.35mm Spinal System is intended to treat scoliosis, kyphosis and lordosis, fracture, loss of stability due to tumor, spinal stenosis, spondylolisthesis, a previously failed fusion surgery or degenerative disc disease (i.e., discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies).
When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the MOSS Miami 6.35mm Spinal System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
The MOSS Miami 6.35mm Spine Systems is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1) and for whom the device system is intended to be removed after solid fusion is attained.
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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Serbaga Buehm
Division of Ger and Neurological Devic
Page 1 of 1
510(k) Number K070302
DePuy Spine, Inc., a Johnson & Johnson Company
Page 4-4
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.