K Number

Device Name

OS2-V Varisation Staple

Manufacturer

IN2Bones SAS

Date Cleared

2015-02-26

(99 days)

Product Code

JDR

Regulation Number

888.3030

Intended Use

The OS2®-V Varisation Staples are indicated for Akin type osteotomies.

Device Description

The OS2®-V Varisation Staple is a metallic staple with two self- drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface. Sizes: The OS2®-V Varisation Staple is available in various angles (90° and 26°) and interaxis (8mm and 10mm). Material: The OS2®-V Varisation Staple is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. It does not have any coating. Single use: The OS2®-V Varisation Staple is designed for single use only. Sterilization: The OS2®-V Varisation Staple is supplied sterile, using gamma irradiation. Place of use: The OS2®-V Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K991566, K070033

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description is for a simple metallic surgical staple and contains no mention of software, algorithms, or any technology that would suggest AI/ML.

Therapeutic

Yes
The device is a metallic staple used to correct valgus deformation of the first ray, which is a therapeutic intervention for a medical condition.

Diagnostic

No
The device, OS2®-V Varisation Staples, is a metallic staple used in surgical procedures (Akin type osteotomies) to correct valgus deformation of the first ray. It is an implantable medical device used for treatment, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

The device description clearly states it is a metallic staple, which is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the OS2®-V Varisation Staple is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
The OS2®-V Varisation Staple is a surgical implant used to correct bone deformities. It is a physical device inserted into the body during a surgical procedure.

The description clearly indicates its use in a surgical setting for a specific type of osteotomy (bone cutting procedure). This falls under the category of a surgical device or implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OS2®-V Varisation Staples are indicated for Akin type osteotomies.

Product codes

JDR

Device Description

The OS2®-V Varisation Staple is a metallic staple with two self- drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface.
Sizes: The OS2®-V Varisation Staple is available in various angles (90° and 26°) and interaxis (8mm and 10mm).
Material: The OS2®-V Varisation Staple is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. It does not have any coating.
Single use: The OS2®-V Varisation Staple is designed for single use only.
Sterilization: The OS2®-V Varisation Staple is supplied sterile, using gamma irradiation.
Place of use: The OS2®-V Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital, or outpatient surgery center where sterile field may be created and maintained.

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)

Not Found

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

Not Found

Predicate Device(s)

K991566, K070033

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.

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

February 26, 2015

IN2Bones SAS % Norman F. Estrin, Ph.D. Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K143323 Trade/Device Name: OS2®-V Varisation Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: January 18, 2015 Received: January 29, 2015

Dear Dr. Estrin:

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

Page 2 – Norman F. Estrin, Ph.D.

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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" (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 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 yours,

Mark N. Melkerson -S

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

Enclosure

004_Indications for Use.pdf

K143323 page 1/1

Indications for Use

510(k) Number (if known):	Not yet assigned
Device Name:	OS2®-V Varisation Staple
Indications For Use:	The OS2®-V Varisation Staples are indicated for Akin type osteotomies.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/3/Picture/0 description: The image shows the logo for IN2BONES. The logo is inside of a gray oval shape. The text "IN2BONES" is in white, except for the number "2" which is in orange. There is a white swoosh on the left side of the oval.

005_510(k) Summary.pdf

510(k) SUMMARY For In2Bones OS2®-V Varisation Staple

| Sponsor identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment registration number | 3010470577 |
| Date of preparation | 20th February 2015 |
| Contact person | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Email: estrin@yourFDAconsultant.com |
| Authorized Agent in the United States | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Email: estrin@yourFDAconsultant.com |
| Proprietary Name | OS2®-V Varisation Staple |
| Common name | Bone Varisation staple |
| Device classification regulation | 21 CFR 888.3030: Single/multiple component metallic bone
fixation appliances and accessories
Class II |
| Device Product Code and Panel | JDR: staple, fixation, bone
87 orthopedics |

| Device Description | The OS2®-V Varisation Staple is a metallic staple with two self- drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface.
Sizes: The OS2®-V Varisation Staple is available in various angles (90° and 26°) and interaxis (8mm and 10mm).
Material: The OS2®-V Varisation Staple is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138. It does not have any coating.
Single use: The OS2®-V Varisation Staple is designed for single use only.
Sterilization: The OS2®-V Varisation Staple is supplied sterile, using gamma irradiation.
Place of use: The OS2®-V Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Devices | Integra / Newdeal SOLUSTAPLE (K991566)
Memometal Varisation staple (K070033) |
| Indications for use: | The OS2®-V Varisation Staples are indicated for Akin type osteotomies |

COMPARISON OF THE INDICATIONS FOR USE WITH THE PREDICATE DEVICES:

As with the predicate devices, the OS2°-V Varisation Staple is indicated for surgical implantation longer than 30 days in the fixation of bone fractures or for bone reconstruction.

510k number	K991566	Substantial equivalence discussion
manufacturer	In2Bones	Integra / Newdeal
Name of device	OS2®-V Varisation Staple	SOLUSTAPLE	OS2®-V Varisation Staple has exactly the same indications for use as the SOLUSTAPLE: “Akin type osteotomy”
Indications for use	The OS2®-V Varisation Staples are indicated for Akin type osteotomies.	The SOLUSTAPLE® is indicated for Akin type osteotomy

| 510k number | K070033 | Substantial equivalence
discussion |
|-----------------------|--------------------------------|--------------------------------------------------|
| manufacturer In2Bones | Memometal Varisation
staple | OS2®-V Varisation Staple
has exactly the same |

| Name of
device | OS2®-V Varisation
Staple | Varisation staple | indications for use as the
Memometal Varisation |
|------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------|
| Indications
for use | The OS2®-V
Varisation Staples are
indicated for Akin
type osteotomies. | The Memometal
Varisation Staple is
indicated for Akin type
osteotomy | staple: “Akin type
osteotomy” |

| Comparison of
Technological
characteristics | The technological characteristics of the OS2®-V Varisation
Staple are the same as the characteristics of predicate devices in
terms of intended use and design. All these implants have the
following features:

Insertion into bone: The OS2®-V Varisation Staple and all
predicate devices are intended for surgical implantation
into bone for longer than 30 days.
Indications for use: The OS2®-V Varisation Staple has
similar indications for use when compared to the Integra /
Newdeal SOLUSTAPLE (K991566) and Memometal
Varisation staple (K070033): all are indicated for Akin
type osteotomies.
Design: The OS2®-V Varisation Staple has similar design,
when compared to the Integra / Newdeal SOLUSTAPLE
(K991566) and Memometal Varisation staple (K070033):
all are staples with self-drilling tips, available in straight
and angle designs, manufactured from 1mm diameter
wire.
Equivalent size range: The OS2®-V Varisation Staple has
similar size range, when compared to the Integra /
Newdeal SOLUSTAPLE (K991566) and Memometal
Varisation staple (K070033): all are staples available in
8mm and 10mm interaxis, 10mm leg length, 26° and 90°
angulation options.
Material: OS2®-V Varisation Staple has similar raw
material, when compared to the Integra / Newdeal
SOLUSTAPLE (K991566) and Memometal Varisation
staple (K070033): all are manufactured from stainless
steel 316L, according to ISO 5832-1 and ASTM F138.
The OS2®-V Varisation Staple has similar intended use
and mechanical properties when compared to the Integra /
Newdeal SOLUSTAPLE (K991566) and Memometal
Varisation staple (K070033). Indeed, they are all
compliant with standard ISO 8827 “Implants for surgery –
staples with parallel legs for orthopaedic use – general
requirements”. |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence Summary | The OS2®-V Varisation Staple has similar technological
characteristics when compared to the predicate devices.
Substantial equivalence discussion is provided here below: |

510k number	K991566	K070033
manufacturer	In2Bones	Integra / Newdeal	Memometal Varisation staple
Name of device	OS2®-V Varisation Staple	SOLUSTAPLE	Varisation staple
Use	Single use	Single use	Single use
Fixation	Bone	Bone	Bone
Indications for use	The OS2®-V Varisation Staples are indicated for Akin type osteotomies	The SOLUSTAPLE® is indicated for Akin type osteotomy	The Memometal Varisation Staple is indicated for Akin type osteotomy
Design	Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire.	Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire.	Staple with self-drilling tips, available in straight and angle designs, manufactured from 1mm diameter wire.
size	available in 8mm and 10mm interaxis, 10mm leg length
26° and 90° angulation options	available in 8mm and 10mm interaxis, 10mm leg length
26° and 90° angulation options	available in 8mm and 10mm interaxis, 10mm leg length
26° and 90° angulation options
Raw material	stainless steel 316L, according to ISO 5832-1 and ASTM F138	stainless steel 316L, according to ISO 5832-1 and ASTM F138	stainless steel 316L, according to ISO 5832-1 and ASTM F138

Substantial Equivalence Comparison and Discussion

indications of the OS2®-V Varisation Staples are substantially equivalent to the predicate devices identified in the 510(k) submission. No new materials or processes are used in the development of this implant.

The OS2®-V Varisation Staples are acceptable for the application.