BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
Applicant
Biomet Manufacturing Corp
Product Code
HRS · Orthopedic
Decision Date
Mar 28, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3030
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Biomet Reconstructive Wedges are intended to be used for internal bone fixation for bone structures, fusions or osteotomies in the ankle and foot, such as: Open wedge osteotomies of Hallux Valgus Evans lengthening osteotomies Metatarsal/cuneiform arthrodesis Biomet Reconstructive Wedges are intended for use with ancillary fixation. Biomet Reconstructive Wedges are not intended for use in the spine.
Device Story
Biomet Reconstructive Wedges are metallic blocks for insertion into bone voids to facilitate alignment in foot/ankle surgery. Available in oval and rectangular shapes with varying dimensions; feature rectangular cut-out windows for allograft packing. Constructed as completely porous structures to promote tissue ingrowth, with a solid titanium 'skin' on the outer edge for insertion instrumentation and part marking. Used by orthopedic surgeons in clinical settings to stabilize bone structures during fusions or osteotomies. Requires ancillary fixation for stability. Benefits patient by providing structural support for bone healing and alignment.
Clinical Evidence
No clinical data submitted. Substantial equivalence determined via non-clinical bench testing, including static/dynamic compression, static shear strength, expulsion testing, compressive strength, porosity/pore size, interconnectivity, roughness, tensile adhesion, Taber abrasion, and MR compatibility.
Technological Characteristics
Metallic bone fixation wedges; porous structure with solid titanium outer edge. Dimensions vary by width, length, and thickness. Designed for internal fixation with ancillary hardware. Non-clinical testing evaluated mechanical properties (shear, compression), surface characteristics (roughness, porosity), and MR compatibility.
Indications for Use
Indicated for internal bone fixation, fusions, or osteotomies in the ankle and foot, including Hallux Valgus open wedge osteotomies, Evans lengthening osteotomies, and metatarsal/cuneiform arthrodesis. Requires ancillary fixation. Contraindicated for use in the spine.
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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Image /page/0/Picture/0 description: The image contains the logo for Biomet Manufacturing Corp. The logo is in black and white. The word "BIOMET" is in a stylized font, and the words "MANUFACTURING CORP." are below the logo in a smaller font.
### K122770 Page 1/2
## MAR 2 8 2013
### 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| SUBMITTER INFORMATION | |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Biomet Manufacturing Corp. |
| Address | 56 East Bell Drive<br>Warsaw, IN 46582 |
| Phone number | (574) 267-6639 |
| Fax number | (574) 371-1027 |
| Establishment<br>Registration Number | 1825034 |
| Name of contact person | Patricia Sandborn Beres<br>Senior Regulatory Specialist<br>Biomet Manufacturing Corp. |
| Date prepared | March 21, 2013 |
| NAME OF DEVICE | |
| Trade name | Biomet Reconstructive Wedges |
| Common name | Wedge |
| Classification name | Single/multiple component metallic bone fixation appliances and<br>accessories<br>Smooth or threaded metallic bone fixation fastener |
| Classification panel | Orthopedics |
| Regulation | 21 CFR 888.3030<br>21 CFR 888.3040 |
| Product Code(s) | HRS<br>HWC |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | Wright Medical Technology Inc.'s BIOFOAM® Bone Wedges cleared<br>through the following 510(k)s: K070592, K073535 and K093950. |
| Reason for 510(k)<br>submission | New device |
| Device description | Biomet Reconstructive Wedges are metallic blocks designed for<br>insertion into voids for alignment of bones in the foot or ankle.<br>There are two styles of wedges which are oval and rectangular in<br>shape. Wedges are available in a variety of widths, lengths and<br>thicknesses. Rectangular cut-out windows allow the surgeon to<br>pack allograft within the device. The wedges are completely<br>porous, to allow for tissue ingrowth. There is a "skin" of solid<br>titanium on the outer edge of the component to facilitate the<br>insertion instrument and allow for identifying part marking to be<br>added to the devices. |
| Indications for use | Biomet Reconstructive Wedges are intended to be used for internal<br>bone fixation for bone structures, fusions or osteotomies in the ankle<br>and foot, such as:<br>Open wedge osteotomies of Hallux Valgus Evans lengthening osteotomies Metatarsal/cuneiform arthrodesis |
| | Biomet Reconstructive Wedges are intended for use with ancillary<br>fixation. |
| | Biomet Reconstructive Wedges are not intended for use in the spine. |
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE | |
| Biomet Reconstructive Wedges uses similar technology to the predicate BIOFOAM® Bone Wedge | |
| Devices cleared through 510(k)s K070592, K073535, and K093950. The Biomet Reconstructive | |
| Wedges are similar in material, design and sizing to the predicates. | |
| PERFORMANCE DATA | |
| Non-Clinical Tests Conducted For Determination Of Substantial Equivalence | |
| Chemical Composition | Static Shear Strength |
| Static Compression Testing | Dynamic Compression Testing |
| Expulsion Testing | Compressive Strength |
| Porosity/Pore Size | Taber Abrasion |
| Interconnectivity | Roughness |
| Tensile Adhesion | MR Compatibility |
| Microstructure | Animal Data |
| Clinical Tests Conducted for Determination of Substantial Equivalence and/or of Clinical | |
| Information | |
| No clinical data submitted | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | |
| No clinical data was necessary for a determination of substantial equivalence. | |
| The results of testing indicated the material performed within the intended use, did not raise any new | |
| safety and efficacy issues and were found to be substantially equivalent to the predicate devices. | |
Mailing Address, PO 30, 557 Warsa x 10 46581 0597 Toll Free &CD.348.95,00 C"ice 574 267 8639 14am Fax: 574 267 5137 now Dicmel Com
Shipping Address: 56 East Beat Onve Warsaw. IN 46532
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Image /page/2/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 its wings spread, and three wavy lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 28, 2013
Biomet Manufacturing Corporation % Ms. Patricia Sandborn Beres Senior Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46582
Re: K122770
Trade/Device Name: Biomet Reconstructive Wedges Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 18, 2013 Received: February 20, 2013
Dear Ms. Beres:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Ms. Patricia Sandborn Beres
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Ering of eith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
510(k) Number (if known):_____K1222770
Device Name: Biomet Reconstructive Wedges
Indications For Use:
Biomet Reconstructive Wedges are intended to be used for internal bone fixation for bone structures, fusions or osteotomies in the ankle and foot, such as:
- Open wedge osteotomies of Hallux Valgus .
- Evans lengthening osteotomies .
- Metatarsal/cuneiform arthrodesis .
Biomet Reconstructive Wedges are intended for use with ancillary fixation.
Biomet Reconstructive Wedges are not intended for use in the spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
## Elizabeth|崎原ank -S
Division of Orthopedic Devices
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23
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.
