510(k) · Cleared
ClearedAffirm (TM) VCF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Algea Therapies · NDN Cement, Bone, Vertebroplasty
Cleared on Oct 25, 2011 as substantially equivalent to K041454 (Kyphon, Inc., 2004) after a 197-day review. Its family tree reaches back 3 generations to 1998. 6 later devices descend from it.
- Decided
- Oct 25, 2011
- Review
- 197 days
- Class
- Class II
- Product code
- NDN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981251 (1998). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK981251 Kyphon Inflatable Bone TampKyphon, Inc. · 1998 · Recalled
- 2 generations backK032212 Kyphx Directional Inflatable Bone Tamp, Models K16A and K17AKyphon, Inc. · 2003
- 1 generation backK041454 Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13AKyphon, Inc. · 2004 · Recalled
- This deviceK110998 Affirm (TM) VCF SystemAlgea Therapies · 2011
- Descendant · cites it directly · 5 of its ownK123942 Stryker Ivas Balloon CatheterStryker Corporation · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK152557 Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 2016
- Descendant · 2 generations on · 1 of its ownK172116 Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker…Stryker Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK172214 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. · 2017
- Descendant · 3 generations on · 0 of its ownK200763 Osteo-site Vertebral BalloonIzi Medical · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K123942Stryker Ivas Balloon CatheterStryker Corporation · 2013 · cites it directly5descendants
- K152557Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. · 2016 · cites it directly2descendants
- K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation · 2018 · 2 generations on1descendant
- K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. · 2017 · 2 generations on1descendant
- K200763Osteo-site Vertebral BalloonIzi Medical · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981251 | Kyphon Inflatable Bone Tamp | Kyphon, Inc. | 1998 | 3 |
| −2 | K032212 | Kyphx Directional Inflatable Bone Tamp, Models K16A and K17A | Kyphon, Inc. | 2003 | — |
| −1 | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13A | Kyphon, Inc. | 2004 | 5 |
| 0 (this device) | K110998 | Affirm (TM) VCF System | Algea Therapies | 2011 | — |
| +1 | K123942 | Stryker Ivas Balloon Catheter | Stryker Corporation | 2013 | 1 |
| +1 | K152557 | Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G21, S.R.L. | 2016 | — |
| +2 | K172116 | Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS… | Stryker Corporation | 2018 | — |
| +2 | K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters | G-21 S.R.L. | 2017 | — |
| +3 | K200763 | Osteo-site Vertebral Balloon | Izi Medical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 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 NDN? 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 NDN device
- #1 K241775 XeliteMed VertehighFix High Viscosity Spinal…score 14.9 · 4 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 |
|---|---|---|---|
| * | K041454 | Kyphx Xpander Inflatable Bone Tamps Model#KO8A,KO9A,K13ASummary page 1…27: Cement/Bone Vertebroplasty Product Code: HRX, NDN Regulatory Class: 11,Panel Code: 87 Predicate(s): KyphX® Inflatable Bone Tamps (K041454) SE date: September 30, 2005 Purpose: The purpose of this submission is to request clearance for the AFFIRMTM VO… | 2004 |
What descends from it? (6)
2 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)
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 13 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K123942 (Stryker Corporation, 2013) has gone furthest, with 5 descendants of its own.
- 22 other devices also cite its predicate K041454.
How does its category compare?
All NDN devicesNDN Cement, Bone, Vertebroplasty: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NDN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDN
90in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDN
4in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDN
626in 2025
MAUDE reports naming product code NDN, 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 | 9 | 128 | 0 | 21 |
| 2008 | 1 | — | 0 | 39 |
| 2009 | 6 | 211 | 1 | 70 |
| 2010 | 5 | 215 | 0 | 396 |
| 2011 | 11 | 164 | 0 | 98 |
| 2012 | 7 | 90 | 0 | 89 |
| 2013 | 7 | 118 | 4 | 242 |
| 2014 | 7 | 106 | 0 | 231 |
| 2015 | 6 | 76 | 0 | 204 |
| 2016 | 4 | 154 | 0 | 182 |
| 2017 | 5 | 125 | 0 | 191 |
| 2018 | 3 | 111 | 0 | 144 |
| 2019 | 2 | — | 0 | 227 |
| 2020 | 4 | 157 | 0 | 212 |
| 2021 | 2 | — | 0 | 344 |
| 2022 | 2 | — | 0 | 270 |
| 2023 | 2 | — | 0 | 311 |
| 2024 | 3 | 90 | 0 | 454 |
| 2025 | 2 | — | 0 | 626 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AFFIRM™ VCF System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine, hand, tibia, radius, and calcaneus. This includes percutaneous vertebral augmentation. Vertebral compression fractures may result from osteoporosis, benign lesions and/or malignant lesions such as metastatic cancer and myeloma. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110998 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110998: Affirm (TM) VCF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110998
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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