The indications are:
Types of Fractures: Simple closed fractures, Comminuted fractures, Open fractures of first, second or third degree, Crush fractures
Antegrade Indications: Femur shaft fractures, Distal femur shaft fractures, Pathological fractures, e.g. tumor osteolysis, Periprosthetic femur fracture in the middle to third part with knee replacement in situ
Retrograde Indications: Supracondylary fractures, Simultaneous nailing of femur and tibia, Distal femur fracture with osteosynthesis or hip prosthesis in situ, Periprosthetic femur fracture at knee arthroplasty
Borderline Indications: Percondylar femur fracture, Pseudarthrosis (only reamed method), Osteoporosis

Device Description

Intramedullary rods are used for the stabilisation of fractures or correction of deformity of ong bones with or without interlocking screws. The connection between the nail and the interlocking screw is realised with central holes or grooves. Reamed and unreamed intramedullary nailing and for the femoral bone the antegrade and retrograde entrance are standard methods today.

agp Bioriqid Nail Femur (BNF) is the consistent development of the Biorigid Nail Tibia for the femoral bone. The BNF is a full material nail. The interlocking of the nail happens with solid Ø 5.3 mm screws through central holes and grooves.

The central holes on the nail protect against rotational forces. The grooves are designed for interlocking possibility over the whole length of the nail and a defined reduction of the rigidity because of the full material nail.

The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions.

aap Biorigid Nail Femur (BNF) incorporates

Nail in different diameters .
Interlocking screws in different lenghts ●
Interlocking nut ●
Protection cap in different lengths ●
CondyLock ●
Accessories, like targeting devices etc. ●

AI/ML Overview

This 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided document. The document primarily establishes the device's intended use, materials, and comparison to existing devices.

Here's a breakdown of why the information is missing:

Acceptance Criteria & Device Performance: The document does not define specific performance metrics (e.g., strength, durability, biocompatibility targets) or report test results against such criteria. The "Performance Standards" section refers generally to cGMP's, ASTM requirements, and harmonized standards like ISO 9001 / EN 46001, but these are quality management and material specification standards, not specific device performance acceptance criteria.
Study Details: Since there's no mention of specific performance testing, there's no information on:
- Sample sizes for test sets
- Data provenance
- Number or qualifications of experts
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone performance studies
- Type of ground truth used
- Training set sample size or ground truth establishment

This document is a regulatory submission for a Class II medical device (intramedullary fixation rod) seeking 510(k) clearance by demonstrating substantial equivalence. For such devices, rigorous clinical trials or extensive performance studies with explicit acceptance criteria are often not required if substantial equivalence to a legally marketed predicate device can be shown. The FDA's letter explicitly states that the device is "substantially equivalent... to legally marketed predicate devices."

What the document does provide in lieu of a performance study:

Predicate Devices: A list of several similar intramedullary nails from other manufacturers that serve as the basis for demonstrating substantial equivalence (e.g., Howmedica Osteonics Corp. T2 Femoral Nail System, Synthes Ti Distal Femoral Nail).
Comparison of Technological Characteristics: It states that the aap Biorigid Nail Femur (BNF) is "substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." This implies that the device is expected to perform similarly to those already on the market without needing to re-prove fundamental performance through new studies.
Material Composition: Specifies the use of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), a well-established and approved material for such implants.
Intended Use: Clearly outlines the types of fractures and anatomical locations for which the device is indicated, which aligns with the predicate devices.

Summary

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AUG 2 6 2002 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitters Name:

aap Implantate AG Lorenzweg 5 12099 Berlin Germany Ph.: +49 30 750 19 0 Fax: +49 30 750 19 111

Biorigid Nail Femur (BNF)

Intramedullary Fixation Rod

Biorigid Femoral Nail System

aap Biorigid Nail Femur (BNF)

cd1782

page 1 of 2

Contact Name: Name of Device: Classification Name:

Common/Usual Name:

Proprietary Name:

Classification:

전 - - - ---------------------------------------------------------------------------------------------------------------------------------------------------------------------

CFR Chapter I, Title 21 § 888.3020,

87 J DS #, # 87 H SB #, # 87 H TN

Class II, Intramedullary Fixation Rod,

Dipl .- Ing. Christian Abel, Director Quality Management

Performance Standards:

Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001.

Material Composition:

aap Biorigid Nail Femur components are manufactured of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136)

Intended Use:

aap Biorigid Nail Femur (BNF) is intended to use in fractures of the femoral bone.

The indications are:

• Types of Fractures:	Simple closed fracturesComminuted fracturesOpen fractures of first, second or third degreeCrush fractures
• Antegrade Indications:	Femur shaft fracturesDistal femur shaft fracturesPathological fractures, e.g. tumor osteolysisPeriprosthetic femur fracture in the middle to third partwith knee replacement in situ
• Retrograde Indications:	Supracondylary fracturesSimultaneous nailing of femur and tibiaDistal femur fracture with osteosynthesis or hipprosthesis in situPeriprosthetic femur fracture at knee arthroplasty
• Borderline Indications:	Percondylar femur fracturePseudarthrosis (only reamed method)Osteoporosis

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Device Description:

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Jofa Kod1782

The BNF permits the execution of different implantation techniques and interlocking with only one nail. Therefore it meets the different injury manners and necessity for individual solutions.

aap Biorigid Nail Femur (BNF) incorporates

Nail in different diameters .
Interlocking screws in different lenghts ●
Interlocking nut ●
Protection cap in different lengths ●
CondyLock ●
Accessories, like targeting devices etc. ●

Predicate Devices for Substantial Equivalence:

aap Implantate AG 's Biorigid Nail Femur (BNF) is similar in size, material and intended use to the Howmedica Osteonics Corp. T2 Femoral Nail System (K010801 / K011622 / K014220), Synthes Ti Distal Femoral Nail (K970733), Synthes Proximal Femoral Nail (K970097), Synthes Titanium Unreamed Femoral Nail (K923597), Smith & Nephew Titanium Nail System (K981529), Smith & Nephew Intramedullary Nail System (K983942), DePuy ACE AIM Titanium Supracondylar Nail (K974781), Biomet Titanium Intramedullary Nails (K982953), Biomet Titanium Retrograde Femoral Nail (K013923)

Comparision of Technological Characteristics: aap BNF is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics.

Sterilisation Information:

The devices are distributed in non sterile condition.

The instruments and implants provided in non-sterile condition must be decontaminated. cleaned and sterilised prior to each surgery. All packaqing materials must be removed.

Recommendations for sterilisation are contained in the package insert.

Note: These devices are sterilised by end users utilizing the approved/outlined quidelines found in the AAMI Guideline "Good Hospital Practice: Steam Sterilisation and Sterility Assurance" and in ANSI/AAMI/ISO 11737 guidelines to achieve the acceptable Sterility Assurance Level (SAL).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles or faces stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 26 2002

AAP Implantate AG Dipl.-Ing. Christian Abel Director Quality Management Lorenzweg 5 12099 Berlin Germany

Re: K021782

Trade/Device Name: aap Biorigid Nail Femur (BNF) Regulation Number: 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: JDS Dated: May 14, 2002 Received: May 30, 2002

Dear Mr. Abel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Christian Abel

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):_K021782

Device Name: BNF

Indications For Use:

Types of Fractures: Simple Closed Fractures Comminuted Fractures Open Fractures of First, Second or Third Degree Crush Fractures

Antegrade Indications: Femur Shaft Fractures Distal Femur Shaft Fractures Pathological Fractures (e.g. Tumor Osteolysis) Periprosthetic Femur Fracture in the Middle of Third Part with Knee Replacement in Situ

Retrograde Indications: Supracondylary Fractures Simultaneous Nailing of Femur and Tibia Distal Femur Fracture with Osteosynthesis or Hip Prosthesis in Situ Periprosthetic Femur Fracture at Knee Arthosplasty

Borderline Indications: Percondylar Femur Fracture, (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number	K021782

Prescription Use	OR	Over-The-Counter Use
------------------	----	----------------------

(Per 21 CFR 801.109)

Over-The-Counter Use__

(Optional Formal 1-2-1

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.