OSS System Indications: • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. • Correction of varus, valgus, or posttraumatic deformity. • Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Ligament deficiencies. • Tumor resections. • Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. * • Revision of previously failed total joint arthroplasty. • Trauma. These devices are to be used with bone cement unless composed of OsseoTi® titanium alloy (not licensed in Canada) or a proximal femur is indicated for use (USA). Zimmer Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (Solely indicated for the USA). * Not applicable to Regenerex® Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. Compress System Indications: The Compress Segmental Femoral Replacement System is indicated for: • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Tumor resections. • Revision of previously failed total joint arthroplasty. • Trauma. The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the OSS System are used with Zimmer Biomet Compress Segmental Femoral Replacement System, the user should refer to the package insert of the Zimmer Biomet Compress Segmental Femoral Replacement System components for information.
Device Story
Modular orthopedic salvage system; provides proximal femoral, distal femoral, total femur, or proximal tibial replacements; includes resurfacing components. Used for bone loss/deformity from tumor resection, trauma, or revision arthroplasty. Components typically cemented; OsseoTi titanium alloy components uncemented. Compress Segmental Femoral Replacement System used for uncemented fixation. Operated by surgeons in clinical/surgical settings. System restores joint function and skeletal stability following significant bone loss or failure of previous implants.
Clinical Evidence
No clinical data. Bench testing only. Process validations performed to confirm manufacturing changes meet existing specifications. Fatigue strength, biological safety, and cleaning evaluations conducted.
Technological Characteristics
Modular orthopedic prosthesis; materials include OsseoTi titanium alloy and other unspecified metals/polymers. Designed for cemented or uncemented (Compress system) fixation. Components include proximal/distal femoral, total femur, and proximal tibial replacements. Manufacturing process modified; device performance validated via fatigue testing and biological safety assessments.
Indications for Use
Indicated for patients with painful/disabled joints due to avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis; varus/valgus/posttraumatic deformity; failed osteotomy, arthrodesis, or joint replacement; ligament deficiencies; tumor resections; non-unions; femoral neck/trochanteric fractures; or trauma. Includes small adults and adolescents (12-21 years) for specific femoral/tibial replacements.
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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FDA U.S. FOOD & DRUG ADMINISTRATION
July 1, 2026
Biomet, Inc.
Yoriko Kobayashi
Regulatory Affairs Principal
56 E Bell Dr.
Warsaw, Indiana 46581
Re: K253434
Trade/Device Name: OSS™ Orthopedic Salvage System
Regulation Number: 21 CFR 888.3350
Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis
Regulatory Class: Class II
Product Code: JDI, KRO
Dated: June 2, 2026
Received: June 3, 2026
Dear Yoriko Kobayashi:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K253434 - Yoriko Kobayashi
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LIMIN SUN -S
Limin Sun, Ph.D.
Assistant Director
DHT6A: Division of Joint
Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K253434 |
| --- | --- |
| Please provide the device trade name(s). | |
| OSS™ Orthopedic Salvage System | |
| Please provide your Indications for Use below. | |
| OSS System Indications: • Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. • Correction of varus, valgus, or posttraumatic deformity. • Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Ligament deficiencies. • Tumor resections. • Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. * • Revision of previously failed total joint arthroplasty. • Trauma. These devices are to be used with bone cement unless composed of OsseoTi® titanium alloy (not licensed in Canada) or a proximal femur is indicated for use (USA). Zimmer Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (Solely indicated for the USA). * Not applicable to Regenerex® Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component. Compress System Indications: The Compress Segmental Femoral Replacement System is indicated for: • Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. • Tumor resections. • Revision of previously failed total joint arthroplasty. • Trauma. The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the OSS System are used with Zimmer Biomet Compress Segmental Femoral Replacement System, the user should refer to the package insert of the Zimmer Biomet Compress Segmental Femoral Replacement System components for information. | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) #: K253434
# 510(k) Summary
Prepared on: 2026-06-02
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | BIOMET, INC. |
| --- | --- |
| Applicant Address | 56 E Bell Dr Warsaw IN 46581 United States |
| Applicant Contact Telephone | 1-800-613-6131 |
| Applicant Contact | Yoriko Kobayashi |
| Applicant Contact Email | yoriko.kobayashi@zimmerbiomet.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | OSS™ Orthopedic Salvage System |
| --- | --- |
| Common Name | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Classification Name | Hip joint metal/polymer semi-constrained cemented prosthesis |
| Regulation Number | 888.3350 |
| Product Code(s) | JDI, KRO |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| --- | --- | --- |
| K123501 | Orthopedic Salvage System (OSS) | JDI |
Device Description Summary
21 CFR 807.92(a)(4)
The OSS™ Orthopedic Salvage System offers a variety of component options for treatment of patients that require proximal femoral, distal femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibia and distal femur. The OSS System offers the surgeon treatments for patients presenting bone loss and deformity associated with bone tumors resection, trauma, and difficult revision arthroplasty. Zimmer Biomet OSS Modular Arthrodesis System and specialty components hip soft tissue claws are also used with the Zimmer Biomet OSS Orthopedic Salvage System.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
OSS System Indications:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Correction of varus, valgus, or posttraumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies.
- Tumor resections.
- Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.*
- Revision of previously failed total joint arthroplasty.
- Trauma.
These devices are to be used with bone cement unless composed of OsseoTi® titanium alloy (not licensed in Canada) or a proximal femur is indicated for use (USA).
Zimmer Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents
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(12-21 years) that require proximal femoral, distal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (Solely indicated for the USA).
* Not applicable to Regenerex® Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
Compress System Indications:
The Compress Segmental Femoral Replacement System is indicated for:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The Compress Segmental Femoral Replacement System components are intended for uncemented use.
When components of the OSS System are used with Zimmer Biomet Compress Segmental Femoral Replacement System, the user should refer to the package insert of the Zimmer Biomet Compress Segmental Femoral Replacement System components for information.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for Use are same between the predicate and the subject device.
## Technological Comparison
21 CFR 807.92(a)(6)
The subject device has the same technical characteristics such as design, material, chemical composition, and principal of operation. The modification proposed in this notification is to the manufacturing process of the devices, and non-clinical tests demonstrates the proposed device is as safe and effective as the predicate devices.
## Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Process validations are completed for the proposed manufacturing process changes to confirm that the proposed processes will produce parts meeting the existing product specifications. Device performance (fatigue strength), biological safety and cleaning of the devices have been evaluated and reviewed for potential impact due to the proposed changes. It concluded that there is no significant impact to safety and effectiveness of devices due to the changes.
Clinical testing not applicable.
The proposed device has the same intended use as the predicate(s). The proposed device has the same technological characteristics to the predicate(s), and the information provided herein demonstrates that:
- any differences do not raise different questions of safety and effectiveness; and
- the proposed device is at least as safe and effective as the legally marketed predicate device(s).
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.
