(235 days)
Not Found
No
The document describes a mechanical device (screws and washers) for bone fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for bone fracture and bone fragment fixation, which is a therapeutic purpose.
No
The device is a system of screws intended for bone fracture and bone fragment fixation, and joint reconstructions, which are therapeutic applications, not diagnostic ones.
No
The device description explicitly states that the device is manufactured from Titanium Alloy and Stainless Steel, indicating it is a physical hardware device (screws) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "bone fracture fixation and bone fragment fixation" and "Minimally invasive fracture / joint reconstructions," etc. These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The device is described as "Cannulated Screws" made of Titanium Alloy and Stainless Steel. These are surgical implants, not reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing information for diagnosis, monitoring, or treatment based on such testing.
In summary, the device is a surgical implant used for orthopedic procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, Femoral neck, femoral head, Femoral supracondylar, Tibial plateau, head of the humerus, head of the tibia, wrist, ankle, elbow, shoulder, Scaphoid, hand, Metatarsal, foot, proximal humerus, acetabulum, dorsal pelvic ring, Malleolar, Navicular, calcaneus, talus, tarsal region
Indicated Patient Age Range
Peadiatric
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K990776, K915316, K950652, K962011, K963192, K895766, K962706, K893512, K810205
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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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).
1
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
2
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
3
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:
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
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
Number K021233