Predicate Devices

K962608, K963045, K992739, K031175, K082572, K092929, K100634, K100952, K103287

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mechanical spinal fixation device and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is a spinal fixation device, indicated as an adjunct to fusion for various spinal conditions, which implies it directly treats or manages a medical condition to restore health.

Diagnostic

No

The device is described as a non-cervical spinal fixation device used as an adjunct to fusion for various spinal conditions, not for diagnosing them.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is comprised of TAN (Titanium-6 Aluminum-7 Niobium), which is a material used in physical medical devices, not software. The performance studies also describe non-clinical testing of physical properties (static compression bending, static torsion, and dynamic compression bending).

IVD (In Vitro Diagnostic)

Based on the provided text, 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.
Device Description and Intended Use: The description clearly states that the Synthes USS are "non-cervical spinal fixation devices" intended for surgical implantation to stabilize the spine. This is a physical medical device used in vivo (within the body), not a test performed in vitro (outside the body).
Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.

Therefore, the Synthes USS is a surgical implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma ( i.e. , fracture or dislocation), deformities or curvatures ( i.e. , scoliosis, kyphosis, and/or lordosis, Scheuermnann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm extension connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mm rod systems to one another.

When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.

In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.

Product codes (comma separated list FDA assigned to the subject device)

NKB, MNH, MNI, KWQ, KWP

Device Description

The Synthes USS Line Extension is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). These components are in-line extension connectors which can connect spinal rods of the same or different diameters. The in-line extension connectors are comprised of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

T1-S2/ilium, T1-L5, T8-L5

Indicated Patient Age Range

skeletally mature patients, pediatric 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Synthes conducted non-clinical testing according to ASTM F1717-10 - static compression bending, static torsion, and dynamic compression bending - to determine that the Synthes USS Connector is substantially equivalent to the predicate devices identified. Clinical data were not

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K962608, K963045, K992739, K031175, K082572, K092929, K100634, K100952, K103287

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

® SYNTHES®
Spine

K113149

510(k) Summary

| Name of Firm: | Synthes Spine
1302 Wrights Lane East
West Chester, PA 19380 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Heather Guerin
Spine Senior Regulatory Affairs Specialist
Telephone: 610-719-5432
Facsimile: 610-719-5102
Email: guerin.heather@synthes.com |
| Date Prepared: | December 30, 2011 |
| Trade Name:
Classification: | Synthes USS Line Extension
21 CFR 888.3050-Spinal interlaminar fixation orthosis
21 CFR 888.3060–Spinal intervertebral body fixation orthosis
21 CFR 888.3070-Pedicle screw spinal system, Class III
Orthopaedic and Rehabilitation Devices Panel |
| Predicates: | Product Code: NKB, MNH, MNI, KWQ, KWP
Synthes USS, K962608
Synthes USS, K963045
Synthes Click'X, K992739
Synthes Click'X, K031175
Synthes USS Illiosacral and Polyaxial, K082572
Synthes Matrix System, K092929
Synthes Matrix System, K100634
Synthes Matrix System, K100952
Synthes 6.0 CoCr and CP Ti-3 Rods, K103287 |
| Device
Description: | The Synthes USS Line Extension is an addition to Synthes' existing non-
cervical spinal fixation devices intended for posterior pedicle screw fixation
(T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-
L5). These components are in-line extension connectors which can
connect spinal rods of the same or different diameters. The in-line
extension connectors are comprised of TAN (Titanium-6 Aluminum-7
Niobium, per ASTM F1295-05). |
| Intended Use/
Indications for
Use: | The Synthes USS are non-cervical spinal fixation devices intended for
posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-
L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to
skeletally mature patients with the exception of the Small Stature USS,
which includes small stature and pediatric patients. These devices are
indicated as an adjunct to fusion for all of the following indications:
degenerative disc disease (defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies),
spondylolisthesis, trauma ( i.e. , fracture or dislocation), deformities or
curvatures ( i.e. , scoliosis, kyphosis, and/or lordosis, Scheuermnann's
Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). |
| | |
| 510(k) Summary
When treating patients with Degenerative Disc Disease (DDD), transverse
bars are not cleared for use as part of the posterior pedicle screw
construct. | |
| When used with the 3.5/6.0mm parallel connectors, the Synthes USS
6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In
addition, when used with 3.5/5.0mm parallel connectors, the Synthes
Small Stature USS can be linked to the CerviFix 3.5mm Systems. When
used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature
USS can be linked to the Synthes USS 6.0mm rod systems. When used
with the 5.5/6.0mm extension connectors, Matrix can be linked to the
Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can
be used to link all Synthes USS 6.0mm rod systems to one another. | |
| When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes
USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm
Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm
tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm
Systems, respectively. When used with the 5.5/6.0mm tapered rods, the
Synthes USS 6.0mm rod systems can be linked to the Matrix System. | |
| In addition, Synthes USS 6.0mm rod systems can be interchanged with all
USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-
chromium-molybdenum alloy and titanium grade 3 rods, which can only be
used with Pangea. | |
| Synthes USS
6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening,
USS VAS variable axis components, USS Fracture, Click'X,
Click'X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial,
USS Iliosacral, ClampFix 5.5mm Rod System: Matrix 5.0mm Rod System: USS Small Stature | |
| CerviFix
3.5mm Rod Systems: CerviFix, Axon, Synapse 4.0mm Rod System: Synapse | |
| Comparison of
the device to
predicate
device(s):
Performance
Data
(Non-Clinical
and/or Clinical): | |
| The intended use, indications for use, and materials of manufacture of the
subject devices are the same as the predicate Synthes USS. The overall
design and function of the predicate(s) are unaffected by the current
additions.
Synthes conducted non-clinical testing according to ASTM F1717-10 -
static compression bending, static torsion, and dynamic compression
bending - to determine that the Synthes USS Connector is substantially
equivalent to the predicate devices identified. Clinical data were not | |

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ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

2

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 1 2012

Synthes Spine % Ms. Heather Guerin 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K113149

Trade/Device Name: Synthes USS Connectors Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: MNI, NKB, MNH, KWQ, KWP Dated: December 30, 2011 Received: January 03, 2012

Dear Ms. Guerin:

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

3

Page 2 - Ms. Heather Guerin

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/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,

incerely yours,

F.C

Nso Lin Dn
M. J. N. Mcllveen

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

Image /page/4/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K113149". The characters are written in a cursive style, and the numbers are clearly distinguishable.

@ SYNTHES Spine

Indications for Use Statement

510(k) Number: K113149 Device Name: Synthes USS Connectors

The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5), Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discognitude in pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), turnor, stenosis, and failed previous usion (pseudoarthrosis).

When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5/6.0mm parallel connectors, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0mm rod systems. When used with the 5.5/6.0mm extension connectors, Matrix can be linked to the Synthes USS 6.0mm rod systems. 6.0/6.0mm extension connectors can be used to link all Synthes USS 6.0mm rod systems to one another.

When used with the 3.5/6.0mm and 4.0/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 3.5/5.5mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5mm and 4.0mm Systems, respectively. When used with the 5.5/6.0mm tapered rods, the Synthes USS 6.0mm rod systems can be linked to the Matrix System.

In addition, Synthes USS 6.0mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.

Synthes USS

6.0mm Rod Systems: USS Side-Opening, USS Dual-Opening, USS VAS variable axis . components, USS Fracture, Click'X, Click'X Monoaxial, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix
5.5mm Rod System: Matrix .
- 5.0mm Rod System: USS Small Stature

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

CerviFix
8

.

3.5mm Rod Systems: CerviFix, Axon, Synapse .
. 4.0mm Rod System: Synapse

510(k) Number k11349

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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