K042344 · Aesculap, Inc. · LWJ · Mar 16, 2005 · Orthopedic
Device Facts
Record ID
K042344
Device Name
EXCIA TOTAL HIP SYSTEM
Applicant
Aesculap, Inc.
Product Code
LWJ · Orthopedic
Decision Date
Mar 16, 2005
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 888.3360
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Excia Hip System is intended to replace a hip joint. The device is intended for: - patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. - Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis - Patients suffering from disability due to previous fusion - Patients with acute femoral neck fractures The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
Device Story
Total hip replacement system; replaces diseased or damaged hip joint. Components: femoral stems (cemented CoCr or uncemented Ti with plasma spray), acetabular cups (Ti with plasma spray), acetabular inserts (UHMWPE), and femoral heads (CoCrMo or ceramic). Distal centralizers (PMMA) maintain stem alignment in femoral canal. Used by orthopedic surgeons in clinical/surgical settings. Provides structural replacement of hip joint to restore mobility and reduce pain. Ceramic heads restricted to Ti cementless stems; CoCrMo heads compatible with both stem types. Acetabular screws optional for fixation.
Clinical Evidence
Bench testing only. Testing performed per FDA guidance for orthopedic devices, including metallic plasma-sprayed coatings, non-articulating modular components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, and UHMWPE requirements.
Technological Characteristics
Materials: Ti, Ti plasma spray (Plasmapore), CoCrMo, UHMWPE, PMMA. Components: Femoral stems (cemented/uncemented), acetabular cups, acetabular inserts (symmetrical/asymmetrical), femoral heads (CoCrMo/ceramic). Distal centralizers for alignment. Fixation: Cemented or cementless. No software or electronic components.
Indications for Use
Indicated for patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of femoral head, nonunion of femoral fractures, congenital hip dysplasia, protrusion acetabuli, slipped capital femoral epiphysis, disability from previous fusion, or acute femoral neck fractures.
Regulatory Classification
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
Trident Porous Ti Acetabular Component with Coating (K013475)
Submission Summary (Full Text)
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# MAR 1 6 1005
# KO42344
PAGE 1 of 2
### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990
# EXCIA TOTAL HIP SYSTEM
### February 25, 2005
Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
- CONTACT: Joyce Kilroy; Dir of RA & QA 800-258-1946 (phone) 610-791-6882 (fax) joyce.kilroy@aesculap.com (email)
TRADE NAME: Excia Total Hip System
COMMON NAME: Hip System
DEVICE CLASS: CLASS II
PRODUCT CODE: LWJ, JDI, LZO
CLASSIFICATION: 888.3350, 888.3353
#### REVIEW PANEL: Orthopedics
### INTENDED USE
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- patients suffering from severe hip pain and disability due to rheumatoid . arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital . femoral epiphysis
- Patients suffering from disability due to previous fusion .
- . Patients with acute femoral neck fractures
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and is intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
## DEVICE DESCRIPTION
The Excia Total Hip System is available with two femoral designs. One is manufactured from Ti with a Ti plasma spray coating (Plasmapore). This component is intended for uncemented use. The other femoral component design is manufactured from CoCrMo and is intended for cemented use. Distal centralizers maintain the stem's alignment in the femoral canal. The centralizers are manufactured from PMMA.
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The acetabular cup (Plasmacup) is manufactured from Ti and is coated with Plasmapore as well. Acetabular cup screws can be used for further cup fixation. The acetabular inserts are UHMWPE and available in symmetrical and asymmetrical designs.
Two femoral heads are available. The CoCrMo heads may be used with either the cemented or cementless femoral stems. However, the ceramic heads are for use only with the Ti alloy cementless stems.
### PERFORMANCE DATA
All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the;
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic . Surfaces Apposing Bone or Bone Cement".
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on . Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
- . "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components",
- "Draft Guidance Document for Testing Acetabular Cup Prostheses", .
- . "Draft Guidance for Femoral Stem Prostheses" .
- "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball . Hip Systems" and
- "Data Requirements for Ultrahigh Molecular Weigt Polyethylene (UHMWPE) Used in . Orthopedic Devices" was completed where applicable.
# SUBSTANTIAL EQUIVALENCE
Aesculap believes that the new Excia Total Hip System is substantially equivalent in design to:
- . BiCONTACT Hip System (K040191)
- 36mm V40 Femoral Head Components (K022077) .
- Alloclassic Zweymueller (K030373) .
- . SC Total Hip System (K031474)
- . Smith & Nephew Hip System (K022902)
- . Pinnacle Duofix HA Acetabular Cup (K031495)
- . Trident Porous Ti Acetabular Component with Coating (K013475)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 6 2005
Ms. Joyce Kilroy Mis. Joyce IIInoulatory Affairs & Quality Assurance Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K042344 Trade/Device Name: Excia Total Hip System Regulation Number: 21 CFR 888.3353; 21 CFR 888.3350 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or ITIP Joint metal corains prosthesis; Hip joint metal/polymer semiconstrained cemented prosthesis Regulatory Class: II
Product Code: LZO, JDI, LWJ Dated: February 25, 2005 Received: February 25, 2005
Dear Ms. Kilroy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becamed the device is substantially equivalent (for the indications ferenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encrosure) to regars comment date of the Medical Device Amendments, or to comments provide to May 20, 1978, the exact and on the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). allo Cosmetic Acr (Free) market the device, subject to the general controls provisions of the Act. The 1 ou may, merelore, manel and not include requirements for annual registration, listing of general controls provisioning 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 If your device to such additional controls. Existing major regulations affecting your device can may be subject to back added as a legulations, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Obacements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r icase be devilsed that I Dr. Pressan that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must or any I odotal statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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## Page 2 - Ms. Joyce Kilroy
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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) This letter will allow you to oegill marketing your arrive of your device of your device to a legally premarket notification. The PDA inding of substance of 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 If you desire specific advice for your at 240-276-0120. Also, please note the regulation entitled, comaci the Office of Comphalloo at 210 = 10 = 21 = 2 = 2 = 2 = 2 = 2 = 2 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = 0 = \$ Small " Misofanding by Icrerches to premantonions.com the Act from the Division of Small other gelleral information on your response in the toll-free number (800) 638-204 or
Manufacturers, International and Consumer Assistance at its to the program of the progra Manufacturels, International and Consumer Pisotows. Ida.gov/cdrh/industry/support/index.html.
Sincerely yours,
J. Mark A. Millerson
Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Excia Hip System
Page 1 of 1
### INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K042344
### Device Name: Excia Total Hip System
### Indication for Use:
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- patients suffering from severe hip pain and disability due to rheumatoid arthritis, # osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral o epiphysis
- Patients suffering from disability due to previous fusion ◆
- Patients with acute femoral neck fractures →
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti with a Ti plasma spray.
| Prescription Use | X | or | Over-the-Counter Use |
|----------------------|---|----|----------------------|
| (per 21 CFR 801.109) | | | |
*for* Mark A. Millan
(Division Sign-Off)
Division of General, Restorative, and Neuro
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
**510(k) Number** K042344
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.
