510(k) · Cleared
Recalled · 2005Compression Hip Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pfizer, Inc. · KIT Media And Components, Synthetic Cell And Tissue Culture
Cleared on Apr 19, 1985 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled once.
- Decided
- Apr 19, 1985
- Review
- 46 days
- Class
- Class I
- Product code
- KIT
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK850886 Compression Hip Screw SystemPfizer, Inc. · 1985
- Descendant · cites it directly · 15 of its ownK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
- Descendant · 2 generations on · 8 of its ownK970258 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of…Ferguson Medical · 1997
- Descendant · 3 generations on · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K955306Omega+ Compression Screw SystemHowmedica Corp. · 1996 · cites it directly15descendants
- K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…Ferguson Medical · 1997 · 2 generations on8descendants
- K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · 3 generations on7descendants
- K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999 · cites it directly3descendants
- K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850886 | Compression Hip Screw System | Pfizer, Inc. | 1985 | — |
| +1 | K955306 | Omega+ Compression Screw System | Howmedica Corp. | 1996 | 1 |
| +2 | K970258 | Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable… | Ferguson Medical | 1997 | — |
| +3 | K022139 | Hip Tool Implant | Orthopedic Sciences, Inc. | 2002 | — |
| +1 | K984331 | Odi Ultimate Compression Hip Screw | Orthopedic Designs, Inc. | 1999 | — |
| +2 | K033286 | Odi Talon Long Proximal Femoral Nail System | Orthopedic Designs, Inc. (Odi) | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2011 | 1 | 0 |
| 2023 | 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 KIT? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 163 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 |
|---|---|---|---|---|
| Jan 25, 2005 | Not classified | Z-1865-2008 | Process control | Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K955306 (Howmedica Corp., 1996) has gone furthest, with 15 descendants of its own.
How does its category compare?
All KIT devicesKIT Media And Components, Synthetic Cell And Tissue Culture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KIT
FDA has decided no KIT device since 2007.
Median 510(k) review, days · KIT
Too few KIT 510(k)s in any year since 2007 to give a median.
Recalls per year · KIT
4in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIT
1in 2020
MAUDE reports naming product code KIT, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 4 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K850886 · printed Nov 6, 2026
Cite this page
510(k) Report. “K850886: Compression Hip Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K850886
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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