510(k) · Cleared
ClearedArcos Interlocking Distal Stems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Dec 7, 2010 as substantially equivalent to K090757 (Biomet, Inc., 2009) after a 292-day review. Its family tree reaches back 6 generations to 1994. 7 later devices descend from it.
- Decided
- Dec 7, 2010
- Review
- 292 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921308 (1994). 25 ancestors in all, the oldest K921274 (1994). 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK921308 HG Multilock Hip Prosthesis W/ TI-NidiumZimmer, Inc. · 1994 · Recalled
- 5 generations backK972893 Partnership Revision Femoral StemsHowmedica Corp. · 1997
- 4 generations backK983404 Type 3 Femoral ComponentsHowmedica Corp. · 1998 · Recalled
- 3 generations backK013106 2 Piece Modular Hip StemHowmedica Osteonics Corp. · 2002 · Recalled
- 2 generations backK022549 Restoration Modular SystemHowmedica Osteonics Corp. · 2002 · Recalled
- 1 generation backK090757 Biomet Modular Femoral Revision SystemBiomet, Inc. · 2009 · Recalled
- This deviceK100469 Arcos Interlocking Distal StemsBiomet Manufacturing Corp · 2010
- Descendant · cites it directly · 4 of its ownK152903 REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016
- Descendant · 2 generations on · 3 of its ownK191374 Revival Modular Hip StemCorin U.S.A. Limited · 2019
- Descendant · 2 generations on · 2 of its ownK201657 Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS…Corin, Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK241472 Icona Hip StemCorin U.S.A. Limited · 2024
- Descendant · 4 generations on · 0 of its ownK261576 Icona Hip StemCorin, Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152903REVIVAL (TM) Modular Revision Hip StemCorin USA · 2016 · cites it directly4descendants
- K191374Revival Modular Hip StemCorin U.S.A. Limited · 2019 · 2 generations on3descendants
- K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd. · 2021 · 2 generations on2descendants
- K241472Icona Hip StemCorin U.S.A. Limited · 2024 · 3 generations on1descendant
- K261576Icona Hip StemCorin, Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921308 | HG Multilock Hip Prosthesis W/ TI-Nidium | Zimmer, Inc. | 1994 | 1 |
| −5 | K972893 | Partnership Revision Femoral Stems | Howmedica Corp. | 1997 | — |
| −4 | K983404 | Type 3 Femoral Components | Howmedica Corp. | 1998 | 1 |
| −3 | K013106 | 2 Piece Modular Hip Stem | Howmedica Osteonics Corp. | 2002 | 37 |
| −2 | K022549 | Restoration Modular System | Howmedica Osteonics Corp. | 2002 | 3 |
| −1 | K090757 | Biomet Modular Femoral Revision System | Biomet, Inc. | 2009 | 18 |
| 0 (this device) | K100469 | Arcos Interlocking Distal Stems | Biomet Manufacturing Corp | 2010 | — |
| +1 | K152903 | REVIVAL (TM) Modular Revision Hip Stem | Corin USA | 2016 | — |
| +2 | K191374 | Revival Modular Hip Stem | Corin U.S.A. Limited | 2019 | — |
| +2 | K201657 | Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular… | Corin, Ltd. | 2021 | — |
| +3 | K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024 | — |
| +4 | K261576 | Icona Hip Stem | Corin, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 KWA? 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? (2)
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 | K042774 | FDA’s K042774 is Mallory-Head Modular Calcar Stems with Interlocking Slots Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| * | K090757 | Biomet Modular Femoral Revision SystemSummary page 2…p~2 Legally Marketed Devices To Which Substantial Equivalence Is Claimed: KG42774 Mallory-Head® Modular Calcar Stems with Interlocking Slots-Biomet K090757 Biomet& Modular Femoral Revision System Device Description: The Arcos TM Interlocking Distal Stem was designe… | 2009 |
| † | K982953 | Titanium Intramedullary Nails-Various Styles | 1998 |
What descends from it? (7)
3 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?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 12 of the 25 ancestors have a recall of any class.
- Of its descendants, K152903 (Corin USA, 2016) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K090757.
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
The Arcos™ Interlocking Distal Stems are single-use implants, intended for uncemented applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100469: Arcos Interlocking Distal Stems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100469
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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