K021380 · Biomet, Inc. · JDI · May 28, 2002 · Orthopedic
Device Facts
Record ID
K021380
Device Name
OSS LES PROXIMAL FEMORAL COMPONENT
Applicant
Biomet, Inc.
Product Code
JDI · Orthopedic
Decision Date
May 28, 2002
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3350
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement. Indications: 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis 2) Correction of varus, valgus or post traumatic deformity 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement 4) Ligament deficiencies 5) Tumor resections 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques 7) Revision of previously failed total joint arthroplasty 8) Trauma This device is a single use implant.
Device Story
OSS Les Proximal Femoral Component is a surgical implant for proximal femoral or total femur replacement. It integrates with Biomet's Oncology Salvage System (OSS), utilizing diaphyseal segments, intramedullary stems, and distal femur/hinged knee components. Designed for orthopedic surgical use in patients with severe joint disease, trauma, or tumor-related bone loss. The device combines design features from previous OSS proximal femoral components. It is a single-use implant intended to restore joint function and stability, alleviate pain, and correct anatomical deformities. Surgeons select and implant the component during reconstructive orthopedic procedures.
Clinical Evidence
No clinical data provided; substantial equivalence supported by engineering analysis.
Technological Characteristics
Metal/polymer semi-constrained hip prosthesis. Materials, surface finishes, and processing are similar to predicate devices. Designed for cemented or uncemented use as a proximal femoral component within the Oncology Salvage System.
Indications for Use
Indicated for patients requiring proximal femoral or total femur replacement due to avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis, deformity (varus/valgus/post-traumatic), failed osteotomy/arthrosis/joint replacement, ligament deficiency, tumor resection, non-unions, femoral neck/trochanteric fractures, or trauma.
Regulatory Classification
Identification
A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).
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MAY 2 8 2002
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K0d21380
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#### Summary of Safety and Effectiveness
| Applicant/Sponsor: | Biomet Orthopedics, Inc.<br>P.O. Box 587<br>Warsaw, Indiana 46581-0587 |
|--------------------|------------------------------------------------------------------------|
|--------------------|------------------------------------------------------------------------|
- Contact Person: Patricia Sandborn Beres Biomet Orthopedics, Inc. 56 Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: (574) 267-6639 extension 1278 Fax: (574) 372-1790
Proprietary Name: OSS Les Proximal Femoral Component
Classification Name: Prosthesis, Hip, semi-constrained, metal/polymer, cemented (888.3350) and Prosthesis, Hip, semi-constrained, metal/polymer, uncemented (888.3358) - when used as proximal femoral
Legally Marketed devices to Which Substantial Equivalence is Claimed: Proximal Femoral Components previously cleared in 510(k) K002757 for the Oncology Salvage System.
Device Description: The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components.
The OSS Les Proximal Femoral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.
> MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587
SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582
OFFICE 219.267.6639
FAX 219.267.8137
E-MAIL biomet@biomet.com
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021380
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Indications For Use: The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following:
- 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
- 2) Correction of varus, valgus or post traumatic deformity
- 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
- 4) Ligament deficiencies
- 5) Tumor resections
- 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 7) Revision of previously failed total joint arthroplasty
- 8) Trauma
Summary of Technologies: The materials, surface finishes, and processing of the OSS Les Proximal Femoral Component are similar to the predicate devices.
Non-Clinical Testing: Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned.
Clinical Testing: None provided
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# MAY 2 8 2002
Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet. Inc. P.O. Box 587 Warsaw, IN 46581-0587
Re: K021380
Trade Name: OSS Les Proximal Femoral Component Regulation Number: 21 CFR 888.3350 and 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
Regulatory Class: Class II Product Code: JDI and LPH Dated: April 24, 2002 Received: May 1, 2002
Dear Ms. Sandborn Beres:
We have reviewed your Section 510(k) premarket 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 May 20, 1970, the enabilities and of the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, (Treefore, market the device, subject to the general controls provisions of the Act. The general thereofs, maintons 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 11 your device 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 r load be actived a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or uny 1 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. Patricia Sandborn Beres
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 premated predicated 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,
R. Mark N. Mdlkess
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): ├од 1380
## Device Name: OSS Les Proximal Femoral Component
#### Indications For Use:
The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement.
Indications:
- 1) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
- 2) Correction of varus, valgus or post traumatic deformity
- 3) Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
- 4) Ligament deficiencies
- 5) Tumor resections
- 6) Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- 7) Revision of previously failed total joint arthroplasty
- 8) Trauma
This device is a single use implant.
(Please do not write below this Line - continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
eral. Restorative and Neurological Devices
Over-The-Counter Use
(Optional Format 1-2-96)
510(k) Number K091380
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.
