510(k) · Cleared
Recalled · Class II · 2021DirectInject
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · GXP Methyl Methacrylate For Cranioplasty
Cleared on Sep 2, 2015 as substantially equivalent to K060763 (Stryker, 2006) and 1 other predicate after a 253-day review. Its family tree reaches back 9 generations to 1987. It has been recalled once.
- Decided
- Sep 2, 2015
- Review
- 253 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K873689 (1987). 19 ancestors in all, the oldest K861369 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 5 generations between
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK060763 Stryker Injectable CementStryker · 2006 · Recalled
- This deviceK143661 DirectInjectStryker · 2015
Show all 9 generations
- Root · 9 generations backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
- 8 generations backK953339 Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc. · 1996
- 7 generations backK973789 Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian…Norian Corp. · 1998
- 6 generations backK991398 Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger · 1999
- 5 generations backK021440 Bonesource HacStryker Instruments · 2002
- 4 generations backK032366 Bonesource Hac Fast Setting CementStryker Instruments · 2003
- 3 generations backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 2 generations backK060061 Stryker Injectable CementStryker Corp. · 2006
- 1 generation backK060763 Stryker Injectable CementStryker · 2006 · Recalled
- This deviceK143661 DirectInjectStryker · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K873689 | Cranioplastic, Acrylic Cranioplasty Material | Dentsply Intl. | 1987 | — |
| −8 | K953339 | Bonesource Hydroxyapatite Cement (Hac) | Osteogenics, Inc. | 1996 | — |
| −7 | K973789 | Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair… | Norian Corp. | 1998 | — |
| −6 | K991398 | Bonesource Hydroxyapatite Cement (Hac) Expanded Kit | Stryker Leibinger | 1999 | — |
| −5 | K021440 | Bonesource Hac | Stryker Instruments | 2002 | — |
| −4 | K032366 | Bonesource Hac Fast Setting Cement | Stryker Instruments | 2003 | — |
| −3 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −2 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| −1 | K060763 | Stryker Injectable Cement | Stryker | 2006 | 1 |
| 0 (this device) | K143661 | DirectInject | Stryker | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060763 | Stryker Injectable CementSummary page 4…e for cranioplasty (882.5300) name: Regulatory Class: Class II Product Code: GXP III. PREDICATE DEVICE Primary Predicate: Stryker Injectable Cement – K060763 This predicate has not been subject to a design-related recall. Secondary Predicate: BoneSource HAC – K021440 This predicate has… | 2006 |
| * | K021440 | Bonesource HacSummary page 4…CATE DEVICE Primary Predicate: Stryker Injectable Cement – K060763 This predicate has not been subject to a design-related recall. Secondary Predicate: BoneSource HAC – K021440 This predicate has not been subject to a design-related recall. Traditional 510(k)… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 1, 2021 | Class II | Z-1436-2021 | Under Investigation by firm | Inability for the user to inject the paste from the syringe into the target location. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 4 other devices also cite its predicate K060763.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
DirectInject is a self-setting, calcium phosphate cement intended to repair neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects not intrinsic to the stability of the bony structure. It is also intended for augmentation or restoration of bony contour in the craniofacial skeleton to include the cranial and zygomatic bones. DirectInject is intended to repair cranial defects with a surface area of 4 cm² or less.
DirectInject is indicated for patients in whom skeletal growth is complete. It can be used in patients with surgically created bone defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143661: DirectInject.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143661
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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