The agp Small and Large Cannulated Screw System is intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. aqp's washers may be used with the screws in certain applications.
Minimally invasive fracture / joint reconstructions .
Additive osteosynthesis for complex joint fractures ●
Multiple- fragment joint fractures .
Femoral neck and femoral head fractures .
Femoral supracondylar fractures ●
Tibial plateau fractures ●
Simple metaphyseal fractures
Simple epiphyseal fractures
Fractures of the head of the humerus o
Fractures of the head of the tibia O
Cooper fractures of the tibia o
Fractures of the radius O
Fractures of the wrist, ankle, elbow and shoulder
Scaphoid fractures and other fractures of the hand ●
Metatarsal fractures and other fractures of the foot ●
Ligament fixation of the proximal humerus ●
Fractures of the acetabulum ●
Fractures of the dorsal pelvic rinq ●
. Condylar fractures
Peadiatric epiphyseal and metaphyseal fractures .
Ligament avulsion injuries (Apohysis) .
Fractures of small ioint bones .
o Malleolar fractures
Navicular fractures o
Fractures of the calcaneus and talus
Arthrodesis of the ankle joint .
Avulsion fracture and metatarsl V
Fractures of the tarsal region

Device Description

The aap Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti Al6 V4 E.L.) and 316 L Stainless Steel. The agp Small and Large Cannulated Screws are available in various length and various thread diameters.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "aap Small and Large Cannulated Screw System." It is a premarket notification to the FDA to demonstrate substantial equivalence to previously approved devices. Therefore, it describes the device's characteristics and its proposed intended use, but it does NOT contain a study proving the device meets specific acceptance criteria as would be found in a performance study for a novel device.

Instead, the submission for this type of device (a Class II orthopedic implant) focuses on demonstrating that it is "substantially equivalent" to existing, legally marketed predicate devices. This involves comparing material composition, intended use, and technological characteristics to show that it raises no new questions of safety or effectiveness.

Because this is a 510(k) submission for substantial equivalence rather than a performance study with acceptance criteria, most of the requested information (sample sizes, ground truth, expert adjudication, MRMC studies) is not applicable or present in this type of document.

Here's how to address the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not present acceptance criteria for performance as would be seen in a clinical trial or a novel device's validation study. Instead, the "performance" here is demonstrating substantial equivalence to predicate devices, primarily through material composition and similarity in intended use.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated in the 510(k))
Material Composition Equivalence: Manufactured from materials identical or equivalent to predicate devices.	The aap Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), and 316L Stainless Steel (ASTM F 138). Comparison: "The aap Small and Large Cannulated Screws are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics."
Intended Use Equivalence: Indications for use are the same as or within the scope of predicate devices.	"The aap Small and Large Cannulated Screw System is intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation." (Followed by a long list of specific fracture types). Comparison: This set of indications is implicitly equivalent to the combined indications of the cited predicate devices.
Technological Characteristics Equivalence: Design features are similar or present no new safety/effectiveness concerns compared to predicate devices.	"The aap Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti Al6 V4 E.L.) and 316 L Stainless Steel. The aap Small and Large Cannulated Screws are available in various lengths and various thread diameters." Comparison: "The aap Small and Large Cannulated Screws are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics."
Manufacturing/Quality Standards: Compliance with relevant industry and regulatory standards.	"Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001."
Sterilization: Clear and acceptable sterilization methods.	"The devices are distributed in non sterile, recommendations for sterilization are contained in package insert. Note: These devices are sterilised by end users utilizing the approved/outlined guidelines 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)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a submission for substantial equivalence based on product design, materials, and intended use comparison, not a study involving a test set of data. There are no patient samples or data provenance mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in the context of clinical data or AI performance studies is not relevant to this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set or adjudication process described.

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

Not applicable. This is not a study assessing reader performance with or without AI. This is a submission for a cannulated screw system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a passive implant (screw system), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The concept of "ground truth" for clinical or AI performance is not relevant to this 510(k) submission for a physical medical device. The "truth" for substantial equivalence is based on the documented characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. No training set is involved as this is not an AI or data-driven device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K021233

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitters Name:

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

Labels	Values
Contact Name:
Name of Device:
Classification Name:
Common/Usual Name:
Proprietary Name:
Classification:

DEC 0 9 2002 Dipl. - Ing. Christian Abel, Director Quality Management aap Small and Large Cannulated Screw System Smooth or Threaded Metallic Bone Fixation Fastener Cannulated Bone Screw aap Small and Large Cannulated Screws Class II, Smooth or Threaded Metallic Bone Fixation Fastener, CFR Chapter I, Title 21 § 888.3040, # 87 H WC #

Performance Standards: Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001. Material Composition: The app Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), and 316L Stainless Steel (ASTM F 138) Intended Use: The aap Small and Large Cannulated Screw System is intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. agp's washers may be used with the screws in certain applications. Specific indications, which are dependent in part of the diameter of the screw, include: Minimally invasive fracture / joint reconstructions, Additive osteosynthesis for complex joint fractures, Multiple- fragment joint fractures, Femoral neck and femoral head fractures, Femoral supracondylar fractures, Tibial plateau fractures, Simple metaphyseal fractures, Simple epiphyseal fractures of the head of the humerus, Fractures of the head of the tibia, Cooper fractures of the tibia, Fractures of the radius, Fractures of the wrist, ankle, elbow and shoulder, Scaphoid fractures and other fractures of the hand, Metatarsal fractures and other fractures of the foot, Ligament fixation of the proximal humerus, Fractures of the acetabulum, Fractures of the dorsal pelvic ring, Condylar fractures, Peadiatric epiphyseal and metaphyseal fractures, Ligament avulsion injuries (Apohysis), Fractures of small joint bones, Malleolar fractures, Navicular fractures, Fractures of the calcaneus and talus, Arthrodesis of the ankle joint, Avulsion fracture and metatarsl V, Fractures of the tarsal region

Device Description: The aap Small and Large Cannulated Screws are manufactured of Titanium Alloy (Ti Al6 V4 E.L.) and 316 L Stainless Steel. The agp Small and Large Cannulated Screws are available in various length and various thread diameters.

Predicate Devices for Substantial Equivalence: aap Cannulated Screws, K990776; ago's Bone Screws, K915316; OSTEOTECH Cannulated Screws, K950652; Synthes -Small and Large Cannulated Screw System, K962011 & K963192; HOWMEDICA ASNIS II Guided Bone Screws, K895766; BIODYNAMIC TECHNOLOGIES EZ-Fix ™ Cannulated Screw System. K962706; DePuy Cannulated Bone Screw, K893512; MECRON Cannulated Bone Screws, K810205; ZIMMER MAGNA-Fx & Mini Magna-Fx Cannulated Screw Fixation System (Stainless Steel) Comparision of Technological Characteristics: The aqp Small and Large Cannulated Screws are substantially equivalent to the predicate devices with respect to physical/technical and material characteristics.

Sterilisation Information: The devices are distributed in non sterile, recommendations for sterilization are contained in package insert. Note: These devices are sterilised by end users utilizing the approved/outlined guidelines 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/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dipl .- Ing. Christian Abel Director Quality Management Research & Development aap Implantate AG Lorenzweg 5 12099 Berlin Germany

Re: K021233

Trade/Device Name: aap Small and Large Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 5, 2002 Received: September 10, 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 fisting (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Mr. Christian Abel

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.

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 snecific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.

iriam C. Provost

for 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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Indications for Use Statement

Page 1 of 1

510(k) Number (if known):

Device Name: agp Small and Large Cannulated Screw System

Indications for Use:

Minimally invasive fracture / joint reconstructions .
Additive osteosynthesis for complex joint fractures ●
Multiple- fragment joint fractures .
Femoral neck and femoral head fractures .
Femoral supracondylar fractures ●
Tibial plateau fractures ●
Simple metaphyseal fractures
Simple epiphyseal fractures
- Fractures of the head of the humerus o
- Fractures of the head of the tibia O
- Cooper fractures of the tibia o
- Fractures of the radius O
Fractures of the wrist, ankle, elbow and shoulder
Scaphoid fractures and other fractures of the hand ●
Metatarsal fractures and other fractures of the foot ●
Ligament fixation of the proximal humerus ●
Fractures of the acetabulum ●
Fractures of the dorsal pelvic rinq ●
. Condylar fractures
Peadiatric epiphyseal and metaphyseal fractures .
Ligament avulsion injuries (Apohysis) .
Fractures of small ioint bones .
- o Malleolar fractures
- Navicular fractures o
Fractures of the calcaneus and talus
Arthrodesis of the ankle joint .
Avulsion fracture and metatarsl V
Fractures of the tarsal region

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

Number K021233

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.