510(k) · Cleared
Recalled · 2002Primaloc Cementless Hip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Development Corp. · KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Cleared on Jan 26, 1996 after a 156-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 26, 1996
- Review
- 156 days
- Class
- Class II
- Product code
- KWY
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK953977 Primaloc Cementless Hip SystemOrtho Development Corp. · 1996
- Descendant · cites it directly · 1 of its ownK021109 Esop CO-CR Femoral HeadsFournitures Hospitalieres · 2002
- Descendant · cites it directly · 1 of its ownK964878 Esop S/C Femoral StemFournitures Hospitalieres · 1998
- Descendant · cites it directly · 0 of its ownK132697 Encompass 10/12 Hip StemOrtho Development Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK050556 Alumina HeadFournitures Hospitalieres Industrie · 2005
- Descendant · 2 generations on · 0 of its ownK021108 Esop HA Femoral StemFournitures Hospitalieres · 2002
Most influential descendants
Showing 5 of 5 · See all- K021109Esop CO-CR Femoral HeadsFournitures Hospitalieres · 2002 · cites it directly1descendant
- K964878Esop S/C Femoral StemFournitures Hospitalieres · 1998 · cites it directly1descendant
- K132697Encompass 10/12 Hip StemOrtho Development Corp. · 2014 · cites it directly0descendants
- K050556Alumina HeadFournitures Hospitalieres Industrie · 2005 · 2 generations on0descendants
- K021108Esop HA Femoral StemFournitures Hospitalieres · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K953977 | Primaloc Cementless Hip System | Ortho Development Corp. | 1996 | — |
| +1 | K021109 | Esop CO-CR Femoral Heads | Fournitures Hospitalieres | 2002 | — |
| +1 | K964878 | Esop S/C Femoral Stem | Fournitures Hospitalieres | 1998 | — |
| +1 | K132697 | Encompass 10/12 Hip Stem | Ortho Development Corp. | 2014 | — |
| +2 | K050556 | Alumina Head | Fournitures Hospitalieres Industrie | 2005 | — |
| +2 | K021108 | Esop HA Femoral Stem | Fournitures Hospitalieres | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWY device
- #1 K253357 b-ONE® Bipolar Headscore 11.2 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2002 | Not classified | Z-0567-03 | Other | Cleaning agent residue from packaging material was adhering to implantable hip stems. |
| Dec 26, 2002 | Not classified | Z-0566-03 | Other | Cleaning agent residue from packaging material was adhering to implantable hip stems. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021109 (Fournitures Hospitalieres, 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KWY devicesKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWY
126in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWY
180in 2025
MAUDE reports naming product code KWY, 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 | 0 | — | 25 | 370 |
| 2008 | 3 | 123 | 0 | 900 |
| 2009 | 1 | — | 24 | 961 |
| 2010 | 4 | 187 | 1 | 688 |
| 2011 | 1 | — | 0 | 758 |
| 2012 | 1 | — | 1 | 978 |
| 2013 | 2 | — | 2 | 1,148 |
| 2014 | 1 | — | 0 | 1,055 |
| 2015 | 1 | — | 0 | 1,213 |
| 2016 | 1 | — | 3 | 877 |
| 2017 | 1 | — | 2 | 826 |
| 2018 | 3 | 219 | 1 | 1,380 |
| 2019 | 5 | 126 | 1 | 1,530 |
| 2020 | 1 | — | 0 | 1,259 |
| 2021 | 0 | — | 0 | 276 |
| 2022 | 2 | — | 0 | 208 |
| 2023 | 2 | — | 0 | 178 |
| 2024 | 0 | — | 1 | 209 |
| 2025 | 1 | — | 2 | 180 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K953977 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953977: Primaloc Cementless Hip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953977
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026