510(k) · Cleared
ClearedEXCIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Aug 18, 2006 after a 63-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 12 later devices descend from it.
- Decided
- Aug 18, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- LWJ
- Recalls
- None
- Predicates
- 1
12 later devices descend from it, 4 citing it directly.
- This deviceK061699 EXCIAAesculap, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK163577 Ecofit® Hip SystemImplantcast GmbH · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK180263 EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018
- Descendant · 2 generations on · 4 of its ownK203420 EcoFit® Hip SystemImplantcast GmbH · 2021
- Descendant · 2 generations on · 3 of its ownK210678 implaFit® hip stemsImplantcast GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK240834 EcoFit® short stem cementless cpTiImplantcast GmbH · 2024
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K163577Ecofit® Hip SystemImplantcast GmbH · 2017 · cites it directly9descendants
- K180263EcoFit Vit E Acetabular SystemImplantcast GmbH · 2018 · cites it directly5descendants
- K203420EcoFit® Hip SystemImplantcast GmbH · 2021 · 2 generations on4descendants
- K210678implaFit® hip stemsImplantcast GmbH · 2022 · 2 generations on3descendants
- K240834EcoFit® short stem cementless cpTiImplantcast GmbH · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061699 | EXCIA | Aesculap, Inc. | 2006 | — |
| +1 | K163577 | Ecofit® Hip System | Implantcast GmbH | 2017 | 1 |
| +1 | K180263 | EcoFit Vit E Acetabular System | Implantcast GmbH | 2018 | — |
| +2 | K203420 | EcoFit® Hip System | Implantcast GmbH | 2021 | — |
| +2 | K210678 | implaFit® hip stems | Implantcast GmbH | 2022 | — |
| +2 | K240834 | EcoFit® short stem cementless cpTi | Implantcast GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K042334 | FDA’s K042334 is Allura 3D-CA, Release 1 Our reading of the summary gave K042334, FDA’s number for Allura 3D-CA, Release 1 (Philips Medical Systems North America Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Acetabular Cups (Plasmacup® SC)”. Kept off the family tree. Summary page 1…ves that the Acetabular Cups (Plasmacup® NSC and MSC) are substantially equivalent to the Acetabular Cups (Plasmacup® SC) that are cleared in the Excia Total Hip System (K042334). DEVICE DESCRIPTION The Acetabular Cups (Plasmacup® NSC and MSC) are manufactured from Ti. and are offered with a plasmapore® c… | 2004 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163577 (Implantcast GmbH, 2017) has gone furthest, with 9 descendants of its own.
How does its category compare?
All LWJ devicesLWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWJ
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · LWJ
Too few LWJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LWJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LWJ
51in 2025
MAUDE reports naming product code LWJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 10 | 68 |
| 2008 | 1 | — | 2 | 72 |
| 2009 | 1 | — | 2 | 84 |
| 2010 | 0 | — | 0 | 132 |
| 2011 | 1 | — | 0 | 255 |
| 2012 | 1 | — | 0 | 390 |
| 2013 | 0 | — | 1 | 522 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 310 |
| 2016 | 0 | — | 0 | 293 |
| 2017 | 0 | — | 0 | 311 |
| 2018 | 0 | — | 0 | 227 |
| 2019 | 0 | — | 0 | 210 |
| 2020 | 0 | — | 0 | 189 |
| 2021 | 0 | — | 0 | 155 |
| 2022 | 0 | — | 0 | 91 |
| 2023 | 0 | — | 2 | 72 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 0 | — | 0 | 51 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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 ephiphysis * Patients suffering from…
Read the full statement (116 words)
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 ephiphysis
* 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061699 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061699: EXCIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061699
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026