K021233 · Aap Implantate AG · HWC · Dec 9, 2002 · Orthopedic
Device Facts
Record ID
K021233
Device Name
AAP CANNULATED SCREWS
Applicant
Aap Implantate AG
Product Code
HWC · Orthopedic
Decision Date
Dec 9, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3040
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for 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 Story
Cannulated screw system for bone fracture and fragment fixation; utilizes guide pins or wires for placement. Available in various lengths and thread diameters; manufactured from Titanium Alloy (Ti 6Al 4V E.L.I.) and 316L Stainless Steel. Used by orthopedic surgeons in clinical settings for internal fixation of fractures across various anatomical sites, including joints, long bones, and small bones. Provides mechanical stabilization of bone fragments to facilitate healing. Distributed non-sterile; requires end-user steam sterilization per AAMI guidelines.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Materials: Titanium Alloy (ASTM F136) and 316L Stainless Steel (ASTM F138). Design: Cannulated screw system for use with guide pins/wires. Sterilization: Non-sterile, intended for steam sterilization per AAMI/ANSI/ISO 11737 guidelines. Standards: ISO 9001 / EN 46001.
Indications for Use
Indicated for bone fracture and fragment fixation in patients requiring orthopedic intervention, including joint reconstructions, complex joint fractures, femoral, tibial, humeral, radial, wrist, ankle, elbow, shoulder, hand, foot, pelvic, and pediatric fractures, as well as ligament fixation and arthrodesis.
Regulatory Classification
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.
ZIMMER MAGNA-Fx & Mini Magna-Fx Cannulated Screw Fixation System
Submission Summary (Full Text)
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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
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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).
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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:
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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
