510(k) · Cleared
Recalled · Class II · 2020OsteoVation Impact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skeletal Kinetics, LLC · GXP Methyl Methacrylate For Cranioplasty
Cleared on Jan 13, 2017 as substantially equivalent to K051784 (Skeletal Kinetics, LLC, 2005) after a 92-day review. Its family tree reaches back 8 generations to 1987. 1 later device descends from it. It has been recalled 7 times.
- Decided
- Jan 13, 2017
- Review
- 92 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 8 generations to K873689 (1987). 18 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 7 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 6 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 5 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 4 generations backK021440 Bonesource HacStryker Instruments · 2002
- 3 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 2 generations backK042072 Callos CMF Bone Void FillerSkeletal Kinetics, LLC · 2004 · Recalled
- 1 generation backK051784 Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC · 2005 · Recalled
- This deviceK162864 OsteoVation ImpactSkeletal Kinetics, LLC · 2017
- Descendant · cites it directly · 0 of its ownK182742 DB-CMFDimensional Bioceramics, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K182742DB-CMFDimensional Bioceramics, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −7 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −6 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −5 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −4 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −3 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −2 | K042072 | Callos CMF Bone Void Filler | Skeletal Kinetics, LLC | 2004 | 10 |
| −1 | K051784 | Osteovation CMF Bone Void Filler | Skeletal Kinetics, LLC | 2005 | 13 |
| 0 (this device) | K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | 2017 | — |
| +1 | K182742 | DB-CMF | Dimensional Bioceramics, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 GXP? 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 GXP device
- #1 K241027 Permatage Settable Bone Puttyscore 16.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051784 | Osteovation CMF Bone Void FillerSummary page 4…ss II Product Code: GXP III. PREDICATE DEVICE 510(k) Number Product Trade Name Manufacturer Code K051784 OsteoVation® CMF Skeletal Kinetics, GXP Primary… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182742 | DB-CMF | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2020 | Class II | Z-2634-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2597-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2633-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2598-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2635-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 6, 2020 | Class II | Z-2599-2020 | Under Investigation by firm | Bone void filler kits may not maintain its setting characteristics for the labeled shelf-life duration. Use may increase the required surgical and anesthesia time for the patient or possible longer-term health consequences could include… |
| Apr 3, 2020 | Class II | Z-2054-2020 | Process design | Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 18 ancestors have a recall of any class.
- Of its descendants, K182742 (Dimensional Bioceramics, LLC, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GXP
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GXP
87in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXP
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXP
1in 2025
MAUDE reports naming product code GXP, 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 | 3 | 87 | 0 | 8 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 1 | 22 |
| 2010 | 1 | — | 0 | 59 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 1 | 28 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 17 |
| 2017 | 1 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 1 | — | 2 | 9 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 4 | 85 | 0 | — |
What is it indicated for?
OsteoVation Impact is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, other cranialbone defects and craniotomy cuts with a surface area no larger than 25cm2. OsteoVation Impact may be used in the restoration or augmentation of bony contours of the cranialbone skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162864: OsteoVation Impact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162864
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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