510(k) · Cleared
ClearedCamceram TCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cam Implants B.V. · MQV Filler, Bone Void, Calcium Compound
Cleared on Apr 21, 2005 as substantially equivalent to K994337 (Orthovita Co., 2000) and 1 other predicate after a 66-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Apr 21, 2005
- Review
- 66 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990131 (1999). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- 1 generation backK014053 Conduit TCP GranulesDepuyacromed · 2002
- This deviceK050357 Camceram TCPCam Implants B.V. · 2005
- Descendant · cites it directly · 0 of its ownK102937 Osteophil Beta-TCPCytophil, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K102937Osteophil Beta-TCPCytophil, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| −1 | K014053 | Conduit TCP Granules | Depuyacromed | 2002 | — |
| 0 (this device) | K050357 | Camceram TCP | Cam Implants B.V. | 2005 | — |
| +1 | K102937 | Osteophil Beta-TCP | Cytophil, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 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 |
|---|---|---|---|
| * | K994337 | Vitoss Scaffold Synthetic Cancellous Bone Void FillerSummary page 1…Common/Usual Name: Bone void filler Classification Name: Bone void filler 3. PREDICATE DEVICES Proprietary Name: Vitoss scaffold (OrthoVita), K994337 Proprietary Name: Conduit TCPgranules (Depuy Acromed), K014053 4. DEVICE DESCRIPTION CAMCERAM TCP is a p… | 2000 |
| * | K014053 | Conduit TCP GranulesSummary page 1…filler 3. PREDICATE DEVICES Proprietary Name: Vitoss scaffold (OrthoVita), K994337 Proprietary Name: Conduit TCPgranules (Depuy Acromed), K014053 4. DEVICE DESCRIPTION CAMCERAM TCP is a porous calcium phosphate resorbable bone void filler for the repair of… | 2002 |
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 |
|---|---|---|---|
| K102937 | Osteophil Beta-TCP | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K102937 (Cytophil, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 25 other devices also cite its predicate K994337.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
CAMCERAM TCP is a bone void filler is a resorbable implant intended to fill bony void or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050357: Camceram TCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050357
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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