510(k) · Cleared
ClearedPHA S1 Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phamedica, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 29, 2017 as substantially equivalent to K000236 (Interpore Cross Intl., 2000) and 1 other predicate after a 244-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Jun 29, 2017
- Review
- 244 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K950697 (1995). 27 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 3 generations backK071373 Stryker Spine Xia Iii Spinal SystemStryker Spine · 2007 · Recalled
- 2 generations backK083393 Xia 3 Spinal SystemStryker Spine · 2009 · Recalled
- 1 generation backK111940 S 100 Pedicle Screw SystemRenovis Surgical Technologies, LLC · 2012
- This deviceK163011 PHA S1 Spinal SystemPhamedica, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −7 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −3 | K071373 | Stryker Spine Xia Iii Spinal System | Stryker Spine | 2007 | 1 |
| −2 | K083393 | Xia 3 Spinal System | Stryker Spine | 2009 | 1 |
| −1 | K111940 | S 100 Pedicle Screw System | Renovis Surgical Technologies, LLC | 2012 | — |
| 0 (this device) | K163011 | PHA S1 Spinal System | Phamedica, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | K000236 | Synergy VLS Cap Nut Models 2206, 6102Summary page 5…1 Predicate Devices 510k Trade or Proprietary or Manufacturer Predicate Number Model Name Type K000236 Synergy VLS Open Interpore Primary K111940 S 100 Pedicle Screw System Renovis… | 2000 |
| * | K111940 | S 100 Pedicle Screw SystemSummary page 5…rer Predicate Number Model Name Type K000236 Synergy VLS Open Interpore Primary K111940 S 100 Pedicle Screw System Renovis Additional PERFORMANCE DATA The PHA S1 Spinal System has been tested i… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 6 of the 27 ancestors have a recall of any class.
- 11 other devices also cite its predicate K000236.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
Phamedica PHA S1 Spinal System is intended for posterior non-cervical pedicle fixation of Thoracic, Lumbar, Sacral/Iliac Spine in skeletally mature patients, as an adjunct to fusion using autogeneous bone graft or allograft for all of the following indications:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
• Spondylolisthesis
• Trauma (i.e., fracture or dislocation)
• Spinal Stenosis
• Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor
• Pseudoarthrosis
• Failed previous fusion in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163011: PHA S1 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163011
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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