The Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The indications for use of metallic external fixation devices include:

Bone fracture fixation
Osteotomy
Arthrodesis
Correction of deformity
Revision procedures where other treatments or devices have been unsuccessful
Bone reconstruction procedures

Device Description

The Hoffmann II External Fixation System originally cleared under K952730, K971755, K003211 and K031941 includes clamps, couplings and rods used in conjunction with half pins or transfixing pins of the Hoffmann External Fixation System cleared under K861766 and is intended to be used for the stabilization of fractures of the tibia, femur, liumerus, radius or pelvis.

This special 510(k) submission is intended to provide an alternate stainless steel material (Biodir 108) to manufacture Hoffinann II coupling components: Currently the subject Hoffmann II components are manufactured from stainless steel, Custom 455.

AI/ML Overview

Here's an analysis of the provided text regarding the Hoffmann II External Fixation System Line Extension (K102885).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: The alternate material (Biodur 108) must demonstrate equivalent stability and performance to the existing material (Custom 455) for the Hoffmann II coupling components.	"Analysis and testing of the alternate material used on the Hoffmann II External Fixation demonstrated equivalent stability and performance compared to its predicate device." This was achieved by comparing "different contributions of the subject Hoffmann II.External Fixation components made of Custom 455 with components of Hoffmann II. MRI System made from the proposed Biodur material."

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

The document does not specify a distinct "test set" in the context of clinical data or human subject testing. The evaluation was based on material analysis and testing of the device components themselves. Therefore:

Sample size for test set: Not applicable in the context of human subjects or clinical cases. The "test set" would refer to the physical components manufactured from the new and old materials. The exact number of components tested is not provided, but it's implied that enough were tested to draw a conclusion of equivalence.
Data provenance: Not applicable in the context of country of origin or retrospective/prospective clinical data, as this was a materials-based study. The testing was conducted by Howmedica Osteonics Corp.

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

Not applicable. The ground truth for this submission was based on engineering and materials science standards and testing protocols, not on expert clinical opinion or interpretation of medical images/outcomes. The "experts" involved would be materials scientists, engineers, and quality assurance personnel responsible for conducting and interpreting the physical and mechanical tests. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. This was a technical/materials equivalence study, not a clinical study involving human readers or interpretation of results that would require an adjudication method like 2+1 or 3+1. The assessment of "equivalent stability and performance" would be based on predefined engineering metrics and statistical comparisons.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is not mentioned and would not be relevant for this type of submission, which focuses on material equivalence for an existing external fixation system. This involves no AI component or human readers interpreting data.

6. Standalone Performance Study

Yes, in a way. The "analysis and testing" of the alternate material against the existing material for the Hoffmann II coupling components can be considered a standalone performance study in the context of the device's functional integrity and material properties. It describes the performance of the device components (without human intervention in its functionality as an AI would) against established benchmarks (the predicate device's material).

7. Type of Ground Truth Used

The ground truth used was engineering and materials performance data obtained from in vitro testing. This includes metrics related to stability, mechanical properties (e.g., strength, stiffness, fatigue resistance), and potentially biocompatibility, ensuring that the new material performs equivalently to the predicate device's material.

8. Sample Size for the Training Set

Not applicable. This submission is for a medical device's material change, not an AI/machine learning algorithm. Therefore, there is no "training set" in the traditional sense.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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K102885

JAN 1 4 2011

510(k) Summary of Safety and Effectiveness: Hoffmann II, External, FixationLine Extension

Proprietary Name:	Hoffmann II External Fixation System Line Extension
Common Name:	External Fixation System
Classification Name and Reference:	Single Multiple component metallic bone fixation appliance andaccessories, 21 CFR §888.3030 andSmooth or Threaded Metallic Fixation Fastener21 CFR §888.3040
Regulatory Class:	Class II
Product Codes:	87LXT: Appliance, Fixation, Nail/Blade/Plate Combination, MultipleComponents Metal Composite87JEC: Component, Traction, Invasive
For Information contact:	Zamir Bar-DavidRegulatory Affairs consultantHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430(201) 831-6455 (Phone)(201) 831-3365 (Fax)zamir.bardavid@stryker.com
510(k) Alternate Contact Person:	Avital Merl-MarguliesRegulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430(201) 831-6365 (Phone)(201) 831-3365(Fax)avital.merl.margulies@stryker.com (c-mail)
Date Prepared:	September 29, 2010

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Kl02885

Description:

Intended Use:

Hoffmann II External Fixation System consists of a system of clamps, couplings and used to provide stabilization of open and/or unstable fractures of the tibia, femur, humerus, radius or pelvis, and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation.

Indications:

The Hoffman II External Fixation System is intended to be used in the stabilization of open and/or unstable fractures and where the soft tissue injury may proclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The indications for use of metallic exteriial fixation devices include:

Bone fracture fixation ●
Osteotomy .
Arthrodesis .
Correction of deformity 0
Revision procedures where other treatments or devices have been unsuccessful o
Bone reconstruction procedures G

Proposed Modification:

Summary of Data:

Analysis and testing of the alternate material used on the Hoffmann II External Fixation demonstrated equivalent stability and performance compared to its predicate device. This was done by analyzing different contributions of the subject Hoffmann II.External Fixation components made of Custom 455 with components of Hoffmann II. MRI System made from the proposed Biodur material.

ﻟﺴﺎ

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a bird-like figure with three lines forming the body and a wavy line at the bottom.

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

Howmedica Osteonics Corp % Mr. Zamir Bar-David 325 Corporate Drive Mahwah, New Jersey 07430

JAN 1 4 2011

Re: K102885

Trade/Device Name: Hoffmann II External Fixation System Line Extension Regulation Number: 21 CFR 888.3040 Regulation Name: Single multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: JEC, LXT Dated: December 20, 2010 Received: December 21, 2010

Dear Mr. Bar-David:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

. . . . . . . .

and the country of the count

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Page 2 -Mr. Zamir Bar-David

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,

-fy B. nh

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

Enclosure

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Hoffmann II External Fixation Line Extension

Special 510(k)

Indications for Use

510(k) Number (if known): K102885

Device Name: Hoffmann II External Fixation System Line Extension

Indications for Use:

The indications for use of metallic external fixation devices include:

Bone fracture fixation .
Osteotomy . �
. Arthrodcsis
Correction of deformity . �
Revision procedures where other treatments or devices have been unsuccessful . O
Bone reconstruction procedures .

Prescription Use(Part 21 CFR 801 Subpart D)	X
	AND/OR
Over-The-Counter Use(21 CFR 807 Subpart C)

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

Page 1 of 1	Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)

Division of Surgical, Orthopedic,

and Restorative Devices

510(k) Number	K102885	27
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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.