510(k) · Cleared
ClearedSynthes Pangea System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 23, 2005 as substantially equivalent to K992739 (Synthes Spine, 2000) after a 49-day review. Its family tree reaches back 2 generations to 1999. 2 of the 777 devices in its family, counting itself, have a Class I recall. 774 later devices descend from it.
- Decided
- Sep 23, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990745 (1999). 774 later devices descend from it, 21 citing it directly. 2 of the 777 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 1 generation backK992739 Click'xSynthes Spine · 2000 · Recalled
- This deviceK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- Descendant · cites it directly · 659 of its ownK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- Descendant · 2 generations on · 581 of its ownK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 350 of its ownK082914 ClampfixSynthes Spine · 2008
- Descendant · 2 generations on · 349 of its ownK090605 ClampfixSynthes (Usa) · 2009
- Descendant · cites it directly · 348 of its ownK103287 Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011
Showing 5 of 774 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 774 · See all- K082572Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008 · cites it directly659descendants
- K091445CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010 · 2 generations on581descendants
- K082914ClampfixSynthes Spine · 2008 · cites it directly350descendants
- K090605ClampfixSynthes (Usa) · 2009 · 2 generations on349descendants
- K103287Synthes 6.0 Cocr and CPT TI-3 RodsSynthes Spine · 2011 · cites it directly348descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −1 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| 0 (this device) | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| +1 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| +2 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K082914 | Clampfix | Synthes Spine | 2008 | — |
| +2 | K090605 | Clampfix | Synthes (Usa) | 2009 | — |
| +1 | K103287 | Synthes 6.0 Cocr and CPT TI-3 Rods | Synthes Spine | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 7 | 0 |
| 2009 | 7 | 0 |
| 2010 | 11 | 1 |
| 2011 | 12 | 0 |
| 2012 | 33 | 0 |
| 2013 | 38 | 0 |
| 2014 | 43 | 0 |
| 2015 | 55 | 0 |
| 2016 | 46 | 0 |
| 2017 | 54 | 0 |
| 2018 | 52 | 0 |
| 2019 | 38 | 0 |
| 2020 | 49 | 0 |
| 2021 | 36 | 1 |
| 2022 | 46 | 0 |
| 2023 | 69 | 0 |
| 2024 | 68 | 0 |
| 2025 | 54 | 0 |
| 2026 | 54 | 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.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K992739 | Click'xSummary page 1…KWQ, MNH, MNI, NKB Code and 21 CFR 888.3050, 21 CFR 888.3060, 21 CFR 888.3070 Classification: CLASS I! and Class III Predicate: Click'X (K992739) Device Description: The PangeaT M System is similar to the cleared Click'X (K992739). Both are compone… | 2000 |
What descends from it? (774)
See all 77421 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082572 | Uss Iliosacral, Uss Polyaxial | 2008 | 659 |
| K082914 | Clampfix | 2008 | 350 |
| K103287 | Synthes 6.0 Cocr and CPT TI-3 Rods | 2011 | 348 |
| K100952 | Modification to Synthes Matrix System Class I | 2010 | 314 |
| K081684 | Blackstone Pedicle Screw System | 2008 | 277 |
| K082797 | Blackstone Pedicle Screw System | 2008 | 209 |
| K091717 | Any Plus Spinal Fixation System | 2010 | 130 |
| K110906 | Apex Spine System | 2011 | 103 |
| K072022 | Valeo Pedicle Screw Spinal System | 2007 | 100 |
| K120696 | Tiger Spine System | 2012 | 41 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K082572 (Synthes Spine, 2008) has gone furthest, with 659 descendants of its own.
- 20 other devices also cite its predicate K992739.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea TM), Click'X® Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature…
Read the full statement (257 words)
The Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea TM), Click'X® Monoaxial, Dual-Opening and the Small Stature USS (which includes small stature and pediatric patients) are non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2), a posterior hook fixation system (T1-L5), or as a anterolateral fixation system (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS. These devices are indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis, and failed previous fusion.
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0 mm parallel connectors, the Synthes USS (including the Click'X®, USS VAS variable axis components, and Pangea TM), Click'X® Monoaxial and Dual-Opening USS can be linked to the CerviFix® System. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS (including the Click'X®, USS VAS variable axis components, and PangeaTM), the Click'X® Monoaxial and Dual-Opening USS Systems.
In addition, Synthes USS (including the Click'X®, USS VAS variable axis components, and PangealM), Click'X® Monoaxial and the Dual-Opening USS can be interchanged with all USS 6.0 mm rods and transconnectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052123: Synthes Pangea System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052123
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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