K011716 · New Deal, S.A. · JDR · Aug 30, 2001 · Orthopedic
Device Facts
Record ID
K011716
Device Name
THE UNI-CLIP STAPLE
Applicant
New Deal, S.A.
Product Code
JDR · Orthopedic
Decision Date
Aug 30, 2001
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The UNI-CLIP® STAPLE is implanted for fixation of bone fractures or for bone reconstructions.
Device Story
The UNI-CLIP® STAPLE is a bone fixation device designed to provide controlled, adjustable compression across a fracture or osteotomy site. The device features a geometry that allows for clinical deformation, resulting in narrowing of the staple bridge to achieve compression. It is intended for use by surgeons in orthopedic procedures involving the hand or foot. By providing stable fixation and compression, the device facilitates bone healing and reconstruction. The staple is available in multiple sizes to accommodate various anatomical requirements.
Clinical Evidence
Bench testing only. Testing evaluated torque of divergence and strength of compression, confirming performance is equivalent to predicate devices. Resistance to torsion was verified to be in compliance with selected standards.
Technological Characteristics
Bone fixation staple constructed from stainless steel. Operates via mechanical deformation of the staple bridge to induce controlled compression. Dimensions vary by size. No software or electronic components.
Indications for Use
Indicated for fixation of bone fractures or bone reconstruction in the hand or foot, including arthrodesis, mono or bi-cortical osteotomies, fracture management, distal or proximal metatarsal or metacarpal osteotomies, and fixation of osteotomies for Hallux Valgus treatment (e.g., Scarf, Chevron).
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.
Richards Fixation Staples (Smith and Nephew Richards)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo and contact information for a company called "newdeal". The address is listed as NEWDEAL SA, 31 RUE DE LA CONVENTION, PARC D'ACTIVITÉS GARIGLIANO, 38200 VIENNE, FRANCE. The telephone number is (33) 04 74 78 15 15, and the fax number is (33) 04 74 78 15 16. The internet email address is NEWDEALFR@AOL.COM.
AUG 3 0 2001
K 0117/6
# SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION: A. NewDeal SA Parc d'Activitiés Garigliano Rue de la Convention 38 200 VIENNE FRANCE
> Tél. : (33) 4 74 78 15 15 Fax : (33) 4 74 78 15 16
### ESTABLISHMENT REGISTRATION NUMBER: B.
9615741
#### OFFICIAL CONTACT PERSON C.
Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac , MD 20854 estrin@yourFDAconsultant.com Tel. : (301) 279 -2899 Fax : (301) 294-0126
#### DATE OF PREPARATION OF THIS SUMMARY: May 31, 2001 D.
#### UNI-CLIP® STAPLE PROPRIETARY (TRADE) NAME: E.
- Bone fixation staple F. COMMON NAME: True compression, adjustable and controlled.
- CLASSIFICATION NAME AND REFERENCE: ে Staple, Fixation, Bone (21 CFR, Section 888.3040)
SA au capital de 1.000.000 F - Nº Siret 412 111 510 000 19 - NAF 331B - 412 111 510 RCS Vie
000041
{1}------------------------------------------------
- PROPOSED REGULATORY CLASS: Class II H.
- 87JDR DEVICE PRODUCT CODE: I.
- OR J. PANEL CODE: PANEL CODE:
DESCRIPTION OF DEVICE: The UNI-CLIP® STAPLE is designed so that, K. DESCAN TION OF OF OF OF Clanical deformation leads to narrowing of the by widening the "chamond", mosseon can obtain a true compression, adjustable and controlled, with many choices of size.
- The UNI-CLIP® STAPLE is implanted for fixation of bone INTENDED USE: L. fractures or for bone reconstructions.
- The "new" UNI-CLIP® STAPLE is INDICATIONS FOR USE: M. INDICATIONS I ON OBE fractures or for bone reconstruction, Examples includeng :
- Arthrodesis in hand or foot surgery ●
- Mono or Bi-cortical osteotomies in the foot or hand .
- Fractures management in the foot or hand .
- Distal or proximal metatarsal or metacarpal osteotomies .
- Distal of proximal metadisal of meadarpareatment (such as Scarf, Chevron, etc.) .
- PREDICATE DEVICE: The "new" UNI-CLIP® STAPLE is substantially
Collections of the Comment Coast 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 1992 -N. PREDICATE DEVICE: THE TREW UNICOLICAL (K991482), the Memory Staple( DePuy)
equivalent to the UNI-CLIP® STAPLE (K991482), the Memory Staple(Departic equivalent to the ONF-CDF (Biomedical Ent) (K993714), the EIS Dynamic (K904220), the memograph Stapine) (K991962), the HTO Compression staple Memory Staple (Groupe Leptite) Richards Fixation Staples (Smith and Nephew Richards).
### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.
Both the UNI-CLIP® STAPLE have the same intended of use and all are Both the UNFCEII - STAR DE nave also salonies. All are made from stainless steel.
- SUMMARY OF STUDIES: Torque of divergence and strength of compression of P. SUMMARY OF STODIES. " Torque of arrorgents ALE is the same as for the the Rupture torque of the "heve a resistance to torsion in compliance with the selected standard.
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
NewDeal SA c/o Norman F. Estrin, Ph.D. President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K011716 Trade Name: Uni-Clip® Staple Regulation Number: 888.3030 Regulatory Class: II Product Code: JDR Dated: May 30, 2001 Received: June 4, 2001
Dear Dr. Estrin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to vour premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
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# Page 2 - Norman F. Estrin, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your do the same contact the Office of Compliance at additionally 807.10 for m viro diagnestions on the promotion and advertising of your device, (201) 394-4659. Additionally, for questions on are particulars of any and one of any of the regulation entitled, «Misbranding by reference to premarket notification» (21CFR 807.97). Other general entitled, "Missuanding by reicher to premarket nowledged from the Division of Small
information on your responsibilities under the Act may be obtained from (900) (30, 2011) a information on your responsibilities and its toll-free number (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-free number in the University Manufacturers International and Sollass "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark n Mellema
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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# 510(k) Number (if known): K011716
## Device Name: Uni-Clip Staple
## Indications For Use:
The *new" uni-clip® staple is indicated for fixation of bone fracture or for bone reconstraucion, including:
- Arthrodesis in hand or foot surgery .
- Mono or Bi-cortical osteotomies in the foot or hand ●
- Fracture management in the foot or hand ●
- Distal or proximal metatarsal or metacarpal osteotomies .
- Fixation of osteotomies for Hallux Valgus treatment such as . scarf, chevron, etc.
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lo Mark N Mikkelsen
ivision of General, Restorative and Neurological I
510(k) Number
Koll +16
OR
Over-The-Counter Use_No
Prescription Use Yes (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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.
