510(k) · Cleared
Recalled · Class II · 2013Stryker Injectable Cement
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 22, 2006 as substantially equivalent to K060061 (Stryker Corp., 2006) and 1 other predicate after a 185-day review. Its family tree reaches back 8 generations to 1987. 8 later devices descend from it. It has been recalled once.
- Decided
- Sep 22, 2006
- Review
- 185 days
- Class
- Class II
- Product code
- GXP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K873689 (1987). 18 ancestors in all, the oldest K861369 (1986). 8 later devices descend from it, 5 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 backK043334 Bone Source Hac Rapid Setting CementStryker Instruments · 2005
- 1 generation backK060061 Stryker Injectable CementStryker Corp. · 2006
- This deviceK060763 Stryker Injectable CementStryker · 2006
- Descendant · cites it directly · 2 of its ownK241027 Permatage Settable Bone PuttyOrthocon, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK221933 MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK261265 Permatage XT Settable Bone PuttyOrthocon, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253732 Permatage Flowable, Settable Bone PasteOrthocon, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK253854 MONTAGE XT Cranial CementOrthocon, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K241027Permatage Settable Bone PuttyOrthocon, Inc. · 2024 · cites it directly2descendants
- K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc. · 2023 · cites it directly1descendant
- K261265Permatage XT Settable Bone PuttyOrthocon, Inc. · 2026 · 2 generations on0descendants
- K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc. · 2026 · 2 generations on0descendants
- K253854MONTAGE XT Cranial CementOrthocon, Inc. · 2026 · 2 generations on0descendants
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 | K043334 | Bone Source Hac Rapid Setting Cement | Stryker Instruments | 2005 | — |
| −1 | K060061 | Stryker Injectable Cement | Stryker Corp. | 2006 | — |
| 0 (this device) | K060763 | Stryker Injectable Cement | Stryker | 2006 | — |
| +1 | K241027 | Permatage Settable Bone Putty | Orthocon, Inc. | 2024 | — |
| +1 | K221933 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023 | — |
| +2 | K261265 | Permatage XT Settable Bone Putty | Orthocon, Inc. | 2026 | — |
| +2 | K253732 | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | 2026 | — |
| +2 | K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K060061 | Stryker Injectable CementSummary page 1…oration of bony contour in the craniofacial skeleton. Substantial Equivalency Information Stryker® Injectable Cement is substantially equivalent to legally marketed K060061 Stryker® Injectable Cement and K043334 Stryker® HAC Rapid Set Cement. DEPARTMENT OF HEALTH & HUMAN SERVICE… | 2006 |
| * | K043334 | Bone Source Hac Rapid Setting CementSummary page 1…cial skeleton. Substantial Equivalency Information Stryker® Injectable Cement is substantially equivalent to legally marketed K060061 Stryker® Injectable Cement and K043334 Stryker® HAC Rapid Set Cement. DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2005 |
What descends from it? (8)
5 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 |
|---|---|---|---|---|
| Jul 30, 2013 | Class II | Z-2054-2013 | Package design/selection | Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K241027 (Orthocon, Inc., 2024) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K060061.
How does its category compare?
All GXP devicesGXP Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremitiers-rariiotaiii, sgyiit,;.aid pcevis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Stryker® Injectable Cement cured in…
Read the full statement (155 words)
Stryker® Injectable Cement is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremitiers-rariiotaiii, sgyiit,;.aid pcevis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Stryker Injectable Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Stryker® Injectable Cement cured in situ provides an open void/gap filler that call augment provisional hardware (e.g., K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process.
Stryker® Injectable Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060763 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060763: Stryker Injectable Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060763
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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