K021321 · Acu Med, Inc. · HRS · Jul 17, 2002 · Orthopedic
Device Facts
Record ID
K021321
Device Name
WRIST FUSION PLATE
Applicant
Acu Med, Inc.
Product Code
HRS · Orthopedic
Decision Date
Jul 17, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The current Acumed Congruent Bone Plate System includes plates and screws for fractures, fusions, or osteotomies designed specifically for the clavicle, humerus, radius, ulna, metatarsals, malleoulus, tibia, fibula, and metacarpals. The Acumed Wrist Fusion Plate, an addition to the Acumed Congruent Bone Plate System, is designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.
Device Story
Acumed Wrist Fusion Plate is a spherical metallic bone fixation device; used for fusion of small hand bones (hamate, capitate, lunate, triquetral). Plate features holes/slots for screw placement and Kirschner wire positioning; threaded center hole allows accessory attachment. Device is implanted by surgeons to stabilize bones in patients with arthritis, fractures, or carpal instability. It functions as a mechanical fixation appliance to facilitate bone fusion. No software or electronic components involved.
Clinical Evidence
No clinical data provided; performance data assessment not applicable.
Technological Characteristics
Spherical bone plate; material: titanium (ASTM F136); mechanical fixation via screws and Kirschner wires; threaded accessory interface.
Indications for Use
Indicated for fusion of small bones of the hand (hamate, capitate, lunate, triquetral) in patients with pain or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.
Regulatory Classification
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.
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HEUMED, INC.
5885 N.W. Cornelius Pass Road, Hillsboro, Oregon 97124-9432
K021321
Tel (503) 627-9957
page 1 of 1
## 510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information: Acumed, Inc.
5885 NW Cornelius Pass Road Hillsboro, Oregon 97007 U.S.A. Phone: (503) 627-9957 Contact: Carrie McMichael, Regulatory Affairs
Classification Name: Single/multiple component metallic bone fixation and accessories Common Name: Plate, Fixation, Bone Proprietary Name: Wrist Fusion Plate Proposed Regulatory Class: Class II, 21 CFR 888.3030
Legally Marketed Equivalent Device(s): KMI Wrist Fusion System (K991873) Acumed Congruent Bone Plate System (K012655)
Device Description: The Acumed Wrist Fusion Plate is spherical in shape. Holes or slots offer multiple screw placement options. The plate also has holes that may be utilized for provisional tacking or positioning with Kirschner wires to the bones prior to screw installation. A threaded hole in the center of the plate allows for optional accessories to be attached to the plate.
Intended Use: The current Acumed Congruent Bone Plate System includes plates and screws for fractures, fusions, or osteotomies designed specifically for the clavicle, humerus, radius, ulna, metatarsals, malleoulus, tibia, fibula, and metacarpals. The Acumed Wrist Fusion Plate, an addition to the Acumed Congruent Bone Plate System, is designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. This is similar to the KMI Wrist Fusion System intended use and does not raise any new issues of safety and effectiveness.
Technological Characteristics: The Acumed Wrist fusion Plate is a spherical, metal plate made from titanium in conformance with ASTM F136. The KMI Wrist Fusion Plate is a conical, metal plate made from 316L Stainless Steel. Both materials are used in numerous bone plates and screws. There are no technological characteristics that raise new issues of safety and effectiveness.
## An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable
Based upon the similarities between the Acumed Wrist Fusion Plate and the predicate devices studied, the safety and effectiveness of the Acumed Wrist Fusion Plate is substantially equivalent to the predicate devices mentioned above.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them, representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2002
Ms. Carrie McMichael Regulatory Affairs Deputy Acumed. Inc. 5885 NW Cornelius Pass Road Hillsboro, Oregon 97124
Re: K021321 Trade/Device Name: Wrist Fusion Plate Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: II Product Code: HRS Dated: April 22, 2002 Received: April 25, 2002
Dear Ms. McMichael:
-
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 - Ms. Carrie McMichael
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 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 yours.
b. Mark N. Wilkerson
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
KOdl 30 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Wrist Fusion Plate
Indications For Use:
The Wrist Fusion Plate and accessories are designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Millman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021321
(Optional Format 3-10-98)
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.
