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 or retrolisthesis 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 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.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically addressing the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Standard / Test)	Reported Device Performance
Sterilization	ISO 11137-2:2012, Sterilization of healthcare products-Radiation-Part 2: Establishing the sterilization dose	Complies with ISO 11137-2:2012
Endotoxin Limit	USP <85> Bacterial Endotoxin Limit	Complies with USP <85>
Seal Strength	ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials	Complies with ASTM F88/F88M-09
Intervertebral Body Fusion Device Performance	ASTM F 2077-03 Test Methods For Intervertebral Body Fusion Devices	Complies with ASTM F 2077-03
Material (Cage)	INVIBIO PEEK-OPTIMA LTI (Implied acceptance by using this material, aligning with predicate PEEK)	INVIBIO PEEK-OPTIMA LTI
Material (Instrument)	630 Stainless Steel (Implied acceptance by using this material, aligning with predicate)	630 Stainless Steel
Radiographic Marker Material	Tantalum (Implied acceptance by using this material, aligning with predicate)	Tantalum
Physical Dimensions (Height)	8mm, 10mm, 12mm, 14mm (Must match predicate for substantial equivalence)	8mm, 10mm, 12mm, 14mm
Physical Dimensions (Length)	22mm, 26mm, 32mm, 36mm (Must match predicate for substantial equivalence)	22mm, 26mm, 32mm, 36mm
Intended Use	Must be substantially equivalent to predicate device's intended use	Substantially equivalent to predicate device's intended use
Radiological Markers	Presence for intra and post-operative positioning and visualization	Cages contain radiographic tantalum markers

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program. The summary explicitly states:

"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:" (followed by a list of standards).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify sample sizes for non-clinical tests (e.g., how many devices were tested for seal strength or ASTM F2077-03). Non-clinical tests typically refer to laboratory testing of physical and mechanical properties, not patient data. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" is not applicable here as no patient data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as there was no clinical study or patient data involved in establishing ground truth. The "ground truth" for the non-clinical tests was established by adherence to recognized international and national standards (e.g., ISO, USP, ASTM) and comparison to a legally marketed predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical study or patient data requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is an intervertebral body fusion device (an implant), not a software algorithm or AI-based diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the device meets the acceptance criteria (and is substantially equivalent) relies on physical and mechanical performance data obtained from non-clinical testing against recognized industry standards (e.g., ASTM F2077-03) and direct comparison of specifications (materials, dimensions, intended use) to an existing predicate device.

8. The Sample Size for the Training Set

This information is not applicable. The device is an orthopedic implant, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

Summary

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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: +86-631-5788966 Fax: +86-631-5660958 Email: wanghan@wegortho.com

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: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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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

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

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K133053 Page 4 of 4

4 .

		DDD is defined as discogenic backpain with degeneration of the discconfirmed by history andradiographic studies.	implants are intended to be used withsupplement fixation instrumentation,which has been cleared by the FDAfor use in lumbar spine.
		These devices are intended to beused with supplemental fixationinstrumentation, which has beencleared by the FDA for use in thelumbar 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
Patientcontactmaterial	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

{5}------------------------------------------------

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 (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/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 (800) 638-2041 or (301) 796-7100 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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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
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.(b)
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.