The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

Open and Closed Fractures .
Post-traumatic joint contracture which has resulted in loss of range of motion .
. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis or non-union of long bones .
Limb lengthening by epiphyseal or metaphyseal distraction .
Correction of bony or soft tissue deformity .
Correction of segmental bony or soft tissue defects .
Joint arthrodesis .
Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

Osteotomy .
. Revision procedure where other treatments or devices have been unsuccessful
Bone reconstruction procedures .
Fusions and replantations of the foot t
Charcot foot reconstruction ●
Lisfranc dislocations

Device Description

The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.

AI/ML Overview

The provided text pertains to a 510(k) premarket notification for the Hoffmann LRF (Limb Reconstruction Frame) System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical performance studies with specific statistical acceptance criteria.

Therefore, the information requested for acceptance criteria, device performance, sample sizes used for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable (N/A) in this context, as a clinical performance study with such metrics was explicitly not required for this 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable (N/A) - Clinical performance metrics with acceptance criteria were not required as per the 510(k) submission process for this device.	Not Applicable (N/A) - Performance was evaluated based on substantial equivalence to predicate devices through non-clinical testing.

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

Sample Size for Test Set: Not Applicable (N/A) - No clinical test set was used.
Data Provenance: Not Applicable (N/A) - No clinical data was used for a test set.

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

Number of Experts: Not Applicable (N/A) - No clinical test set requiring expert ground truth was performed.
Qualifications of Experts: Not Applicable (N/A)

4. Adjudication Method for the Test Set

Adjudication Method: Not Applicable (N/A) - No clinical test set requiring adjudication was performed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

MRMC Study Done: No.
Effect Size: Not Applicable (N/A) - This device is an external fixation system, not an AI-assisted diagnostic tool.

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

Standalone Study Done: No. This device is an external fixation system, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: Not Applicable (N/A) - No clinical ground truth was established for performance evaluation against a specific diagnostic or prognostic outcome. The "ground truth" in this context refers to the material and mechanical properties of the device meeting established engineering standards and being comparable to predicate devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not Applicable (N/A) - No training set was used as this is not an AI/machine learning device.

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

Ground Truth Establishment for Training Set: Not Applicable (N/A) - No training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Substantial Equivalence):

The Hoffmann LRF (Limb Reconstruction Frame) System demonstrated substantial equivalence by means of non-clinical laboratory testing.

Study Design/Methodology: Non-clinical testing was performed in compliance with ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device."
Tests Conducted: The testing included:
- Static and dynamic frame testing.
- Wire Strength testing.
- Compression testing.
- Bending testing.
- Slipping testing.
- Splitting testing on frame components.
Conclusion of Testing: The testing "demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to devices currently cleared for marketing."
Predicate Devices: The device was compared to the following predicate devices to establish substantial equivalence in intended use, materials, and performance characteristics:
- K031181 External Fixation Systems (Smith & Nephew)
- K041706 Hoffman II Foot Ring
- K003018 Titan Tibial Nail (T2 Nail)
Clinical Testing: The submission explicitly states: "Clinical testing was not required for this submission." This reinforces that the evaluation was based on non-clinical, mechanical, and material comparisons to existing devices.

Summary

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11327

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MAR 2 9 2012

Proprietary Name:	Hoffmann LRF (Limb Reconstruction Frame) System
Common Name:	External Fixation Device
Classification Name and Reference:	Single/multiple component metallic bone fixation appliances and accessories 21 CFR§888.3030
Regulatory Class:	Class II
Product Codes:	87 KTT-Appliance, fixation, nail/blade/plate combination,multiple component
For Information contact:	Estela Celi, Regulatory Affairs AssociateHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-6461 Fax: (201) 831-3461
Date Prepared:	November 8, 2011

510(k) Summary of Safety and Effectiveness

Description:

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the new Hoffmann LRF (Limb Reconstruction Frame) System. The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.

Intended Use:

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K113327

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Indications:

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

Open and Closed Fractures .
Post-traumatic joint contracture which has resulted in loss of range of motion .
Fractures and disease which generally may result in joint contractures or loss of range . of motion and fractures requiring distraction
. Pseudoarthrosis or non-union of long bones
. Limb lengthening by epiphyseal or metaphyseal distraction
Correction of bony or soft tissue deformity .
Correction of segmental bony or soft tissue defects .
. Joint arthrodesis
. Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

. Osteotomy
Revision procedure where other treatments or devices have been unsuccessful .
. Bone reconstruction procedures
Fusions and replantations of the foot .
Charcot foot reconstruction �
Lisfranc dislocations .

Summary of Technologies:

Device comparison showed that the proposed device is substantially equivalent in intended, use, materials and performance characteristics to the following predicate devices:

K031181 External Fixation Systems (Smith & Nephew) �
K041706 Hoffman II Foot Ring
. K003018 Titan Tibial Nail (T2 Nail)

Non-Clinical Testing:

Non-clinical laboratory testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System components to determine substantial equivalence. Non-clinical testing was performed with compliance to ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device." Static and dynamic frame testing was performed. Wire Strength, Compression, Bending, Slipping and Splitting testing was also performed on the frame components. Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to devices currently cleared for marketing.

Clinical Testing: Clinical testing was not required for this submission.

Conclusion: The Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of an eagle or other bird, with its wings spread and head turned to the side.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Howmedica Osteonics Corporation % Ms. Estela Celi Regulatory Affairs Associate 325 Corporate Drive Mahwah, New Jersey 07430

Received: March 16, 2012

MAR 2 9 2012

Re: K113327

Trade/Device Name: Hoffmann LRF (Limb Reconstruction Frame) System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: March 15, 2012

Dear Ms. Celi:

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

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Page 2 - Ms. Estela Celi

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,

for 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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K11332.7

Indications for Use

510(k) Number (if known): K113327

Device Name: Hoffmann LRF (Limb Reconstruction Frame) System

Indications for Use:

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

Open and Closed Fractures .
Post-traumatic joint contracture which has resulted in loss of range of motion .
. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
Pseudoarthrosis or non-union of long bones .
Limb lengthening by epiphyseal or metaphyseal distraction .
Correction of bony or soft tissue deformity .
Correction of segmental bony or soft tissue defects .
Joint arthrodesis .
� Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

Osteotomy .
. Revision procedure where other treatments or devices have been unsuccessful
Bone reconstruction procedures .
Fusions and replantations of the foot t
Charcot foot reconstruction ●
Lisfranc dislocations

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) . (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dall

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

510(k) Number K113327

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.