MILESTONE SPINAL SYSTEM

K133053 · Weigao Orthopaedic Device Co., Ltd. · MAX · Jul 15, 2014 · Orthopedic

Device Facts

• Record ID: K133053
• Device Name: MILESTONE SPINAL SYSTEM
• Applicant: Weigao Orthopaedic Device Co., Ltd.
• Product Code: MAX · Orthopedic
• Decision Date: Jul 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Milestone™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with autogenous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Device Story

Milestone Spinal System consists of lumbar cages manufactured from INVIBIO PEEK-OPTIMA LT1; designed for interbody fusion in lumbar spine. Cages feature hollow geometry for autogenous bone graft packing; angular teeth for endplate grip; tantalum markers for radiographic visualization. Implanted by surgeons via open, minimally invasive posterior, or transforaminal approaches. Used in conjunction with FDA-cleared supplemental fixation instrumentation. Provides structural support and correction during fusion procedures. Benefits patients by facilitating spinal fusion in DDD cases.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing including ASTM F2077-03 (mechanical testing for intervertebral body fusion devices), ASTM F88/F88M-09 (seal strength), and USP <85> (bacterial endotoxin limits).

Technological Characteristics

Materials: INVIBIO PEEK-OPTIMA LT1 (cage), 630 Stainless Steel (instruments), Tantalum (markers). Design: Hollow geometry, angular teeth, convex bullet nose. Dimensions: Heights 8-14mm, Lengths 22-36mm. Sterilization: Radiation. Connectivity: None. Software: None.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two levels from L2 to S1, with or without Grade I Spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment. Requires use with autogenous bone graft and supplemental 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

• CAPSTONE® Spinal System (K073291)

Submission Summary (Full Text)

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K133053 Page 1 of 4

# JUL 1 5 2014

### 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: __________________________________________________________________________________________________________________________________________________

- 7.1 Date of Submission
07/14/2014

- 7.2 Sponsor Identification
### Weigao Orthopaedic Device Co., Ltd.

No 26 Xiangjiang Road, Tourist Resorts Weihai, Shandong, 264203, China

Establishment Registration Number: 3006639944

Contact Person: Han Wang Position: Quality & Technique Manager Tel: [phone] Fax: [phone] Email: [e-mail]

7.3 Designated Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu

### Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 7.4 Identification of Proposed Device

Trade Name: Milestone™ Spinal System Common Name: Intervertebral Body Fusion Device

Regulatory Information: Classification Name: Intervertebral body fusion device Classification: II; Product Code: MAX: Regulation Number: 21 CFR 888.3080; Review Panel: Orthopedic;

#### Intended Use Statement:

The Milestone™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with autogenous bone graft.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

### 7.5 Device Description

The Milestone Spinal System consists of INVIBIO PEEK-OPTIMA LT1 lumbar cages of various lengths and heights, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The cages are provided sterile. The Milestone Spinal System also includes various device specific instruments which are provided non-sterile.

### 7.6 Identification of Predicate Device

510(k) Number: K073291 Product Name: CAPSTONE® Spinal System Manufacturer: Medtronic Sofamor Danek USA, Inc.

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### 7.7 Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- 公 1SO11137-2:2012, Sterilization of healthcare products-Radiation-Part 2: Establishing the sterilization dose:
- ア USP <85> Bacterial Endotoxin Limit;
- ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials; ア
- 公 ASTM F 2077-03 Test Methods For Intervertebral Body Fusion Devices
- 7.8 Clinical Test Conclusion

No clinical study is included in this submission.

- 7.9 Substantially Equivalent (SE) Comparison

| Item | Proposed Device(s) | Predicate Device(s) |
|-------------------|---------------------------------------|---------------------------------------|
| Product Code | MAX | MAX |
| Regulation Number | 21 CFR 888.3038 | 21 CFR 888.3038 |
| Intended Use | The Milestone™ Spinal System is | The CAPSTONE® Spinal System is |
| | indicated for interbody fusion with | indicated for with autogenous bone |
| | autogenous bone graft in patients | graft in patients with degenerative |
| | with degenerative disc disease | disc disease (DDD) at one or two |
| | (DDD) at one or two levels from | contiguous levels from L2 to S1. |
| | L2 to S1. These DDD patients may | These DDD patients may also have up |
| | also have up to Grade I | to Grade I Spondylolisthesis or |
| | Spondylolisthesis or retrolisthesis | retrolisthesis at the involved level. |
| | at the involved level. These patients | DDD is defined as discogenic back |
| | should be skeletally mature and | pain with degeneration of the disc |
| | have had six months of | confirmed by history and radiographic |
| | non-operative treatment. These | studies. These patients should be |
| | implants may be implanted via an | skeletally mature and have had six |
| | open or a minimally invasive | months of non-operative treatment. |
| | posterior approach. Alternatively, | These implants may be implanted via |
| | these implants may also be | an open or a minimally invasive |
| | implanted via transforaminal | posterior approach. Alternatively, |
| | approach. These implants are to be | these implants may also be implanted |
| | used with autogenous bone graft. | via an anterior and/or |
| | | transformational approach. These |

Table 6-1 Comparison of Technology Characteristics

3

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# K133053 Page 4 of 4

4 .

| | | DDD is defined as discogenic back<br>pain with degeneration of the disc<br>confirmed by history and<br>radiographic studies. | implants are intended to be used with<br>supplement fixation instrumentation,<br>which has been cleared by the FDA<br>for use in lumbar spine. |
|--------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| | | These devices are intended to be<br>used with supplemental fixation<br>instrumentation, which has been<br>cleared by the FDA for use in the<br>lumbar spine. | |
| Sterile | | Radiation Sterilized | Radiation Sterilized |
| Single Use | | Yes | Yes |
| Shelf Life | | 4 years | 4 years |
| Performance | | Comply with ASTM F2077-03 | Comply with ASTM F2077-03 |
| Features | | a convex, bullet nose design | a convex, bullet nose design |
| | | angular teeth | angular teeth |
| | | hollow geometry | hollow geometry |
| Patient<br>contact<br>material | Cage | INVIBIO PEEK-OPTIMA LTI | PEEK |
| | Instrument | 630 Stainless Steel | 630 Stainless Steel |
| | radiographic | tantalum | tantalum |
| | maker | | |
| Physical | Height | 8mm, 10mm, 12mm, 14mm | 8mm, 10mm, 12mm, 14mm |
| specification | Length | 22mm, 26mm, 32mm, 36mm | 22mm, 26mm, 32mm, 36mm |

7.10 Substantially Equivalent (SE) Conclusion

Based on the comparison above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 15, 2014

Weigao Orthopaedic Device Company, Limited % Ms. Diana Hong Mid-Link Consulting Company, Limited P.O. Box 120-119 Shanghai, 200120. CHINA

Re: K133053

Trade/Device Name: Milestone Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 13, 2014 Received: June 16, 2014

Dear Ms. Hong:

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

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Page 2 - Ms. Diana Hong

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 [phone] or [phone] 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

# Ronald P. Jean -S for

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

Enclosure

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### 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) K133053

Device Name Milestone Spinal System

Indications for Use (Describe)

The Milestone Spinal System is interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. Alternatively, these implanted via transforaminal approach. These implants are to be used with autogenous bone graft.

DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios.

These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FOR FDA USE ONLY - CARRET PLATE 11:48:00:00

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Anton E. Dmitriev. PhD

# Division of Orthopedic Devices

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