The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restorations Modular System include: - . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - Rheumatoid arthritis, . - Correction of functional deformity, . - Revision procedures where other treatments or devices have failed, and - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
Device Story
Restoration® Modular System is a modular hip prosthesis consisting of proximal body styles and distal stem designs; components are assembled by surgeons in the operating room or in situ using a locking bolt. System allows independent sizing of proximal body and distal stem to optimize fit for individual patient anatomy. Device is press-fit into the proximal femur. Intended for use by orthopedic surgeons in clinical settings for total hip arthroplasty. Output is a mechanical hip joint replacement; assists in restoring joint function and mobility for patients with degenerative disease, fractures, or failed prior implants.
Clinical Evidence
No clinical data provided; substantial equivalence is based on design and mechanical testing.
Technological Characteristics
Modular hip prosthesis system comprising proximal bodies and distal stems. Components are assembled via a locking bolt. Materials, design, and manufacturing methods are consistent with previously cleared Restoration® Modular System components. Intended for press-fit fixation in the proximal femur.
Indications for Use
Indicated for patients requiring primary or revision total hip arthroplasty, including those with severe proximal bone loss. Specific conditions include non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, failed prior treatments, and nonunion or fractures of the proximal femur with head involvement.
Regulatory Classification
Identification
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.
Submission Summary (Full Text)
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# 510(k) Summary of Safety and Effectiveness for the Modifications to the Restoration® Modular System
K040734
| Proprietary Name: | Restoration® Modular System |
|-------------------|-----------------------------|
|-------------------|-----------------------------|
Femoral Hip Prosthesis Name:
Regulatory Class: Class II
*
### Classification Names and References:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis, 21 CFR §888 3353,
Prosthesis, hip, semi-constrained, metal/polymer, uncemented, 21 CFR §888.3350
Hip joint metal/polymer semi-constrained cemented prosthesis, 21 CFR §888.3350
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis, 21 CFR §888.3358
Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicumphosphate
Hip joint metal/polymer constrained cemented or uncemented prosthesis, 21 CFR 888.3310
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis, 21 CFR 8888 3390
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis, 21 CFR 8888 3360
Product Codes: 87 LZO, 87 LWJ, 87 JDI, 87 LPH, 87 MEH, 87 KWZ, 87 KWY, and 87 KWL
| Contact Information: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, New Jersey 07430<br>Phone: (201) 831-5467<br>Fax: (201) 831-6038 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 27, 2004 |
#### Device Description:
The Restoration® Modular Hip System is a modular hip system comprise of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing 19mm Cone Body
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K040734
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and adds a new style of proximal body called the MT3 body for use with the previously cleared distal stem components
#### Intended Use:
The Restoration® Modular System is intended for for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific stoms are designed to the Restoration® Modular System include, non-inflammatory muroutions for aos of the result including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other arminis, corroction of have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
## Substantial Equivalence:
The features of the new components are substantially equivalent to the predicate I he reatures of the no no arities in intended use, materials and design. Mechanical ucvices based on similaries in lievivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical
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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 features a stylized eagle with three horizontal lines representing its wings. The eagle is facing left and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2004
Ms. Vivian Kelly Regulatory Affairs Specialist Stryker Howmedica Osteonics 325 Corporate Drive Mahwah, New Jersey 07430
| Re: K040734 | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device Name: | Restoration Modular System: Addition of the MT3 body;<br>Modification to the 19mm Cone Body |
| Regulation Number: | 21CFR 888.3353; 21CFR 888.3350; 21 CFR 888.3358; 21 CFR 888.3310;<br>21CFR 888.3390; 21CFR 888.3360 |
| Regulation Name: | Hip joint metal/ceramic/polymer semi-constrained cemented or<br>nonporous uncemented prosthesis; Hip joint metal/polymer semi-<br>constrained cemented prosthesis; Hip joint metal/polymer/metal semi-<br>constrained porous-coated uncemented prosthesis; Hip joint<br>metal/polymer constrained cemented or uncemented prosthesis; Hip joint<br>femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis;<br>and Hip joint femoral (hemi-hip) metallic cemented or uncemented<br>prosthesis |
| Regulatory Class: II | |
| Product Code: LZO, LWJ, JDI, LPH, KWZ, KWY, KWL, MEH | |
| Dated: August 2, 2004 | |
Dear Ms. Kelly:
Received: August 4, 2004
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.
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Page 2 - Ms. Vivian Kelly
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.
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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours
Sincerely yours,
Mark M. Millman
Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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# Indications for Use
510(k) Number (if known): K040734
Device Name: Restoration® Modular System
Indications For Use:
The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur. Examples of specific indications for use of the Restorations Modular System include:
- . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
- Rheumatoid arthritis, .
- Correction of functional deformity, .
- Revision procedures where other treatments or devices have failed, and �
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
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 Evantation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
4040734
510(k) Number K0407
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.
