K042959 · DePuy Orthopaedics, Inc. · JDI · Dec 22, 2004 · Orthopedic
Device Facts
Record ID
K042959
Device Name
DEPUY C-STEM AMT HIP PROSTHESIS
Applicant
DePuy Orthopaedics, Inc.
Product Code
JDI · Orthopedic
Decision Date
Dec 22, 2004
Decision
SESE
Submission Type
Special
Regulation
21 CFR 888.3350
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: - A severely painful and/or disabled joint from osteoarthritis, rheumatoid arthritis, or congenital hip dysplasia. - Avascular necrosis of the femoral head. - Acute traumatic fracture of the femoral head or neck. - Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Certain cases of ankylosis. The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.
Device Story
Collarless, tapered, press-fit femoral stem; manufactured from wrought stainless steel (Ortron 90); polished surface. Used in total hip arthroplasty to replace damaged hip joint articulation; provides increased mobility and pain reduction. Implanted by orthopedic surgeons in clinical settings. Device functions as femoral component of total hip prosthesis; used with modular metal or ceramic femoral heads and accessory cement restrictors/centralizers. Cemented fixation only. Benefits patient by restoring joint function and stability.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Collarless, tapered, press-fit femoral stem; material: wrought stainless steel (Ortron 90 conforming to ISO 5832-9); polished finish. Available in 7 sizes with standard or high offset options. Designed for cemented use only. Modular compatibility with metal or ceramic femoral heads.
Indications for Use
Indicated for patients requiring total hip arthroplasty due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, acute traumatic fracture of the femoral head/neck, failed previous hip surgery, or ankylosis, provided sufficient sound bone exists to support components. Cemented use only.
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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# EC 22 2004
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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 20 October 2004 DATE PREPARED: DePuy Orthopaedics, Inc. SPONSOR OF 510(k): 700 Orthopaedic Drive, Warsaw, IN 46581-0988 Establishment Registration Number: 1818910 Dina L. Weissman, J.D. 510(K) CONTACT: Legal Consultant, Regulatory Affairs Tel: (574) 371-4905, Fax: (574) 371-4987 Email: Dweissma@dpyus.jnj.com DePuy® C-Stem AMT Hip Prosthesis TRADE NAME: Total Hip Joint Replacement Prosthesis COMMON NAME: Class II per CFR 888.3350 (JDI) CLASSIFICATION: Hip joint metal/polymer semi-constrained cemented prosthesis Unclassified (LZO) Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or nonporous, uncemented 87JDI or 87LZO DEVICE PRODUCT CODE: C-stem (K982918) cleared October 12, 1998 SUBSTANTIALLY
#### DEVICE DESCRIPTION:
EQUIVALENT DEVICES:
The C-Stem AMT hip is a collarless, tapered, press-fit femoral stem. It is manufactured from wrought stainless steel (Ortron 90° conforming to ISO 5832-9) and is polished overall. The stem is offered in 7 sizes, with each body size having either a standard or high offset. It may be used with commercially available modular femoral heads, either metal or ceramic, to form the femoral component of a total hip prosthesis. Accessory items include previously cleared cement restrictors and centralizers.
Titan hip (K001991) cleared August 31, 2000
### INDICATIONS FOR USE:
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, theumatoid arthritis, or congenital ﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻴﺎﺕ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﺮﻳﻦ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﺎﺑﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﺎﺑﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤﺴﺘﺸﺎﺑﺎﺕ ﺍﻟﻤﺴﺘﺸﻔﻰ ﺍﻟﻤ hip dysplasia.
- Avascular necrosis of the femoral head. 2.
- Acute traumatic fracture of the femoral head or neck. 3.
- Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface 4. replacement arthroplasty, or total hip replacement.
- 5. Certain cases of ankylosis.
- The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.
### SUBSTANTIAL EQUIVALENCE:
Neither the intended use nor the fundamental scientific technologies of the DePuy" C-Stem AMT have changed from the legally marketed predicate devices, the DePuy Titan Porocoat® Hip Prosthesis (K001991) and the DePuy C-Stem System (K982918). They have the same material, intended use, indication method, packaging and method of manufacture. The design, while not identical to the predicates, does not raise of safety or effectiveness. DePuy believes that the DePuy C-Stem AMT is substantially equivalent to these two previously cleared devices.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2004
Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
Re: K042959
Trade/Device Name: C-Stem AMT Hip Prosthesis Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDI, LZO Dated: November 19, 2004 Received: November 22, 2004
Dear Ms. Weissman:
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.
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.
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Page 2 - Dina L. Weissman, J.D.
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 (240) 276-0120. 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 yours,
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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## Indications for Use
510(k) Number (if known): _Ko4 1959 510(R) Name: DePuy® C-Stem AMT Hip Stem
Indications for Use:
Total hip arthroplasty is intended to provide increased patient mobility and reduce paint by replacing Total hip arthroplasty is intended in patients where there is evidence of sufficient sound bone to
the damaged hip joint articulation in patients where is indicated in the fo the damaged hip joint articulation in patients where is evilence of the following conditions:
seat and support the components. Total hip replacement is indicated in the follo
- 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- 2. Avascular necrosis of the femoral head.
- 2. Avascular nocrobis of the femoral head or neck.
- 3. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis,
4. Failed previous hip surgery including joint reconstruction, internent Failed previous mp surgery morading John oplasty, or total hip replacement.
- Certain cases of ankylosis. 5.
The DePuy® C-Stem AMT Hip Stem is indicated for cemented use only.
Prescription Use XXXXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Allen Witte
(Division Sign-Off) (Division of General, Restorative, Divisions Neurological Devices
**510(k) Number** K042955
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.
