Who is the manufacturer of T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

Synthes USA Products, LLC filed the 510(k) submission for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (K162358).

What is the FDA product code for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

MAX. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

SYNFIX Evolution System (K150673); DePuy Spine Concorde Bullet System (K151773); NuVasive Interfixated Interbody System (K160051); T-PAL Spacer System (K100089); T-PAL Titanium Spacer System (K151276).

Who can help prepare an FDA 510(k) submission like T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

K162358 · Synthes USA Products, LLC · MAX · Nov 1, 2016 · Orthopedic

Device Facts

Record ID	K162358
Device Name	T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
Applicant	Synthes USA Products, LLC
Product Code	MAX · Orthopedic
Decision Date	Nov 1, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3080
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.

Device Story

T-PAL Spacer System, T-PAL Titanium Spacer System, and SYNFIX Evolution System are intervertebral body fusion devices. T-PAL systems are radiolucent/titanium spacers providing structural stability in lumbar spine; used with supplemental internal fixation. SYNFIX Evolution is a stand-alone anterior interbody fusion device; includes integrated screws; can be used with supplemental fixation for spinal deformities. Devices are implanted by surgeons in clinical settings to facilitate fusion in skeletally mature patients with degenerative disc disease or spinal deformities. Implants are available in various heights/geometries to accommodate patient anatomy. Benefit: structural support and fusion facilitation in lumbar spine.

Clinical Evidence

Literature analysis of published clinical data provided to support modified indications for use. Clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to subject devices are as safe and effective as predicates. No new bench or clinical testing performed.

Technological Characteristics

Materials: PEEK OPTIMA (ASTM F2026), tantalum (ASTM F560), and Ti-6Al-7Nb (ISO 5832, ASTM F1295). Devices are intervertebral body fusion implants available in various heights and geometries. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain, confirmed by history/radiography) at 1-2 contiguous lumbar levels (L2-S1) or spinal deformities as an adjunct to fusion. Requires 6 months of prior non-operative treatment. Used with autogenous/allogenic bone graft and supplemental internal fixation.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

SYNFIX Evolution System (K150673)
DePuy Spine Concorde Bullet System (K151773)
NuVasive Interfixated Interbody System (K160051)
T-PAL Spacer System (K100089)
T-PAL Titanium Spacer System (K151276)

Related Devices

K162206 — Zavation IBF · Zavation, LLC · Apr 4, 2017
K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System · Alphatec Spine · Sep 3, 2025
K143163 — AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System · Stryker Corporation · Jan 26, 2015
K203742 — IdentiTi ALIF Standalone Interbody System · Alphatec Spine, Inc. · Apr 9, 2021
K232097 — IdentiTi ALIF Interbody Systems · Alphatec Spine, Inc. · Sep 25, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a stylized graphic. The graphic depicts three human profiles facing right, layered on top of each other. The profiles are rendered in a simple, abstract style. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 1, 2016 Synthes USA Products LLC Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767 Re: K162358 Trade/Device Name: T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, OVD Dated: August 22, 2016 Received: August 23, 2016 Dear Eugene Bang: 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## K162358 Page 1 of 3 | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | | Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name T-PAL Spacer System Indications for Use (Describe) The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems. | Type of Use (Select one or both, as applicable) | | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <table style="border:none;"><tr><td><div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div></td><td><div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/14) PSC Publishing Securities (201) 643-6710 ELF {3}------------------------------------------------ K162358 Page 2 of 3 | DEPARTMENT OF HEALTH AND HUMAN SERVICES | |-----------------------------------------| | Food and Drug Administration | | Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) Device Name T-PAL Titanium Spacer System Indications for Use (Describe) The T-PAL Titanium Spacer System is indicated for use as an intervertebral body firsion device in skeletally mature patients with degenerative disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Titanium Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six mon-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/14) PSC Publishing Securities (201) 643-6710 ELF {4}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. K162358 Page 3 of 3 510(k) Number (if known) K162358 Device Name SYNFIX Evolution System #### Indications for Use (Describe) The SYNFIX Evolution Spacer System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of nonoperative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ | 510(k) Summary | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Synthes USA Products, LLC. 325 Paramount Drive Raynham, MA 02767 | | Contact Person | Eugene Bang Regulatory Affairs Associate Telephone: (508) 977-3966 Fax: (508) 828-3797 | | Date Prepared | October 31, 2016 | | Trade Name | T-PAL Spacer System T-PAL Titanium Spacer System SYNFIX Evolution System | | Device Class | T-PAL and T-PAL Titanium Spacer Systems – Class II SYNFIX Evolution System – Class II | | Product Code | T-PAL and T-PAL Titanium Spacer System – MAX SYNFIX Evolution System - OVD | | Common Name | T-PAL and T-PAL Titanium System – Intervertebral Fusion Device With Bone Graft, Lumbar SYNFIX Evolution System - Intervertebral Fusion Device With Integrated Fixation, Lumbar | | Classification Name | T-PAL and T-PAL Titanium System - Intervertebral Body Fusion Device, 21 CFR 888.3080 SYNFIX Evolution System - Intervertebral Body Fusion Device, 21 CFR 888.3080 | | Primary Predicate | SYNFIX Evolution System – K150673 | | Additional Predicate | DePuy Spine Concorde Bullet System - K151773 NuVasive Interfixated Interbody System - K160051 T-PAL Spacer System - K100089 T-PAL Titanium Spacer System - K151276 | {6}------------------------------------------------ | Device Description | V/RCN"cpf "V/RCN"Vkcpkwo "Ur cegt "U{ uvgo " Vj g"V/RCN"Ur cegt "ku"ctcfkqrwuegpvkpvgtdqf { 'hwukqp"f gxkeg"wugf 'lp"eqplwpevkqp'y kj " uwr rigo gpvcnikpvgtpcrihkzcvkqp"\q'r tqxkf g'ust wewtcri'uvcdkkv{ 'p"ungg\cm{ "o cwtg'lpf kxf wcn0' Vj g"V/RCN''Ur cegt 'ku"cxckcdng'"p"xctkqwu'j gki j vw"cpf "i gqo gvtkgu"\q"dguv'ceeqo o qf cg" pf kxkf wenuo'r cyj qnqi { "cpf "cpcvqo kecreqpf kkqpu0Vj geqo r qpgpvu"qhvj ku'f gxleg"ctg" o cpwhcewtgf 'htqo "ctcfkqnwegpvr qn{o gt "cpf "kcpkwo "cmq{0' | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | U[ PHKZ'Gxqnwkqp"U{ uvgo " Vj g'U[ PHKZ'Gxqnwkqp"ku"c"eqo dkpckqp'tcfkqnwegpvcpf 'tcf kqr cs wg'uvcpf/cqpg"cpvgtkqt" no dct'lpvgtdqf { 'f gxleg'f guki pgf "\q"dg'"pugt vgf 'y kaj kp"vj g'lpvgtxgt vgdtcn'f kue "ur ceglp"qtf gt" vq'r tqxkf g'ust wewtcr'uvcdkkv{ 'p"unggvcm{ "o cwtg'lpfkxkf wern10Vjg"U[ PHKZ"Gxqnwkqp'ku" cxckcdng"cu"cuugo drgf 'eqo r qpgpw'kp"xctkqwu'j gki j vu"cpf "i gqo gvtkgu"\q"uwk'lpf kxkf wcr' rcyj qnqi {"cpf "cpcvqo lecrieqpf kkqpu0Vj g"eqo r qpgpw"qhj ku'f gxkeg"ctg"o cpwhcewtgf 'htqo c'tcf kqnwegpvr qn{o gt. 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DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment. | | | Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of non- operative treatment prior to surgery. | | | These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. | | Materials | The materials of the subject devices remain unchanged from the currently marketed predicate devices. The devices are manufactured from PEEK OPTIMA (per ASTM F2026), tantalum (per ASTM F560), and Ti-6Al-7Nb (per ISO 5832, ASTM F1295). | | Summary of Technological Characteristics | The technological characteristics of the subject devices remain unchanged from their currently marketed predicate versions in their design, material, performance, and intended use. | | Summary of the Performance Data | A literature analysis of published clinical data is provided to support the modified Indications for Use. The clinical and radiographic outcomes demonstrate that lumbar interbody fusion devices similar to the subject devices are as safe and effective as the predicate devices for the modified Indications for Use. No additional testing was required as there were no changes to the technological characteristics of the subject devices. | | Conclusion | The Substantial Equivalence Justification provided in the submission demonstrates that the devices are as safe and effective as the predicate devices because the intended use and technological characteristics remain unchanged. |

T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

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Intended Use

Device Story

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Technological Characteristics

Indications for Use

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Identification

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T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Related Devices

Submission Summary (Full Text)

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