K964650 · Depuy, Inc. · LPH · Jun 19, 1997 · Orthopedic
Device Facts
Record ID
K964650
Device Name
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
Applicant
Depuy, Inc.
Product Code
LPH · Orthopedic
Decision Date
Jun 19, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 888.3358
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis, with an appropriate Co-Cr-Mo alloy metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating. This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement. 5. Certain cases of ankylosis.
Device Story
Femoral hip prosthesis; straight-stemmed, collared design; Co-Cr-Mo alloy (Orthochrome) metal femoral ball; porous coating with plasma-sprayed tricalcium phosphate (TCP) on proximal half. Intended for cementless total hip arthroplasty; fixation via biological tissue ingrowth. Used by orthopedic surgeons in clinical settings. Provides joint articulation; reduces pain; increases patient mobility. Device is identical to predicate except for TCP coating; no claims for enhanced fixation or performance permitted.
Clinical Evidence
Clinical results cited as showing the device is comparable to the predicate; no specific study data, sample sizes, or statistical metrics provided in the summary.
Technological Characteristics
Straight-stemmed, collared femoral prosthesis; Co-Cr-Mo alloy (Orthochrome) femoral ball; porous coating; plasma-sprayed tricalcium phosphate (TCP) coating on approximately 50% of the proximal porous surface. Cementless fixation via biological tissue ingrowth.
Indications for Use
Indicated for patients requiring total hip replacement due to osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, acute traumatic fracture of femoral head/neck, failed previous hip surgery, or ankylosis, provided sufficient sound bone exists for seating the component.
Regulatory Classification
Identification
A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.
Predicate Devices
DePuy Inc. AML® % Porocoat® Femoral Implant (P820024, K941847)
Submission Summary (Full Text)
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JUN 19 1997
K964650
# SAFE MEDICAL DEVICES ACT OF 1990
# 510K SAFETY AND EFFECTIVENESS SUMMARY
NAME OF FIRM:
DePuy Inc.
P.O. Box 988
Warsaw, IN 46581-0988
510(k) CONTACT:
Vickie E. Arford, R.N.
Sr. Clinical Research Associate
TRADE NAME:
TCP-coated Porocoat® AML® Femoral Hip Prosthesis
CLASSIFICATION NAME:
Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented, Calcium-Phosphate
SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy Inc. AML® % Porocoat® Femoral Implant (P820024, K941847)
# INTENDED USE AND DEVICE DESCRIPTION:
The primary objective of total hip arthroplasty in general is to provide for increased mobility in the patient by reducing pain and replacing the damaged hip joint articulation.
This femoral hip prosthesis, with an appropriate Co-Cr-Mo alloy (Orthochrome®) metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate:
1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
5. Certain cases of ankylosis.
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis is a % porous coated, straight-stemmed, collared prosthesis with a thin coating of tricalcium phosphate sprayed onto approximately ½ of the porous coating of the implant and is designed to be used as the femoral component in total hip replacement without cement.
# BASIS OF SUBSTANTIAL EQUIVALENCE:
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis and the DePuy Inc. AML® % Porocoat® Femoral Implant are both intended for cementless use as the femoral component in total hip replacement. The devices are identical except for the thin coating of TCP plasma sprayed onto approximately ½ of the proximal porous coating. Clinical results show that the TCP-coated Porocoat® AML® Femoral Hip Prosthesis is comparable to the DePuy Inc. AML® % Porocoat® Femoral Implant.
000003
{1}
SAFE MEDICAL DEVICES ACT OF 1990
510K SAFETY AND EFFECTIVENESS SUMMARY
NAME OF FIRM:
DePuy Inc.
P.O. Box 988
Warsaw, IN 46581-0988
510(k) CONTACT:
Vickie E. Arford, R.N.
Sr. Clinical Research Associate
TRADE NAME:
TCP-coated Porocoat® AML® Femoral Hip Prosthesis
CLASSIFICATION NAME:
Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented, Calcium-Phosphate
SUBSTANTIALLY EQUIVALENT DEVICES:
DePuy Inc. AML® % Porocoat® Femoral Implant (P820024, K941847)
INTENDED USE AND DEVICE DESCRIPTION:
The primary objective of total hip arthroplasty in general is to provide for increased mobility in the patient by reducing pain and replacing the damaged hip joint articulation.
This femoral hip prosthesis, with an appropriate Co-Cr-Mo alloy (Orthochrome®) metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate:
1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
5. Certain cases of ankylosis.
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis is a % porous coated, straight-stemmed, collared prosthesis with a thin coating of tricalcium phosphate sprayed onto approximately ½ of the porous coating of the implant and is designed to be used as the femoral component in total hip replacement without cement.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis and the DePuy Inc. AML® % Porocoat® Femoral Implant are both intended for cementless use as the femoral component in total hip replacement. The devices are identical except for the thin coating of TCP plasma sprayed onto approximately ½ of the proximal porous coating. Clinical results show that the TCP-coated Porocoat® AML® Femoral Hip Prosthesis is comparable to the DePuy Inc. AML® % Porocoat® Femoral Implant.
000004
{2}
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Vickie E. Arford, R.N.
Senior Clinical Research Associate
DePuy Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Re: K964650
TCP-coated Porocoat® AML® Femoral Hip Prosthesis
Regulatory Class: II
Product Codes: LPH and MEH
Dated: March 20, 1997
Received: March 21, 1997
Dear Ms. Arford:
We have reviewed your Section 510(k) 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 been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). This decision is based on consideration of the specific design of stem and coating composition detailed in this application. You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitation:
You may not label or in any way promote these devices for enhanced clinical or radiographic performance, enhanced biological fixation and/or long-term stable fixation. The data presented support equivalence with no additional claims over a conventional porous-coated uncemented hip prosthesis (i.e., biological fixation, only).
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Page 2 - Vickie E. Arford, R.N.
Additional limitations for more specific claims of safety and effectiveness may be forthcoming. Should additional limitations be applied you will be contacted in writing to inform you of the additional labeling limitations.
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.
You may market your device under the above limitations as class II devices. These devices would be considered not substantially equivalent to a legally marketed predicate device if labeled with other intended uses and/or claims of safety or effectiveness. Any other intended uses or claims may cause the device to be classified into Class III under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing.
Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
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Page 3 - Vickie E. Arford, R.N.
If you desire specific advice for your device on our labeling regulation—(21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and Restorative Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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510(k) Number: K964650
Device Name: TCP-coated Porocoat® AML® Femoral Hip Prosthesis
Indications for Use:
The TCP-coated Porocoat® AML® Femoral Hip Prosthesis, with an appropriate Co-Cr-Mo alloy metal femoral ball, is intended to be used as the femoral component in total hip replacement. This femoral hip prosthesis is indicated for cementless use and fixation by biological tissue ingrowth into the porous coating.
This prosthesis may be used where x-ray evidence of sufficient sound bone to seat the femoral component exists. The prosthesis may be used for total hip replacement in the following indications, as appropriate:
1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.
5. Certain cases of ankylosis.
Concurrence of CDRE, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
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.
