510(k) · Cleared
ClearedPezo Interbody Cages System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 17, 2011 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 5 other predicates after a 78-day review. Its family tree reaches back 6 generations to 2001. 4 later devices descend from it.
- Decided
- Mar 17, 2011
- Review
- 78 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K010530 (2001). 15 ancestors in all, the oldest P950002 (1996). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 4 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 3 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 2 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 1 generation backK082014 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2008
- This deviceK103814 Pezo Interbody Cages SystemUlrich GmbH & Co. KG · 2011
- Descendant · cites it directly · 2 of its ownK152620 Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK162760 Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK173175 Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK122957 Tezo Titanium Cage FamilyUlrich GmbH & Co. KG · 2013
Most influential descendants
Showing 4 of 4 · See all- K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc. · 2016 · cites it directly2descendants
- K162760Spine Wave Anterior Cervical Spine SystemSpine Wave, Inc. · 2017 · 2 generations on1descendant
- K173175Paramount Anterior Cervical Cage SystemSpine Wave, Inc. · 2017 · 3 generations on0descendants
- K122957Tezo Titanium Cage FamilyUlrich GmbH & Co. KG · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −4 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −3 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −2 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −1 | K082014 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2008 | — |
| 0 (this device) | K103814 | Pezo Interbody Cages System | Ulrich GmbH & Co. KG | 2011 | — |
| +1 | K152620 | Spine Wave Gen II Expandable Interbody System | Spine Wave, Inc. | 2016 | — |
| +2 | K162760 | Spine Wave Anterior Cervical Spine System | Spine Wave, Inc. | 2017 | — |
| +3 | K173175 | Paramount Anterior Cervical Cage System | Spine Wave, Inc. | 2017 | — |
| +1 | K122957 | Tezo Titanium Cage Family | Ulrich GmbH & Co. KG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 2…ASTM F560. Confidential: pezo Tm Family T~ f)Page 22 Predicate Devices: Lumbar I/F Cage® (P960025) Ray TFC TM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083… | 1999 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 2…f)Page 22 Predicate Devices: Lumbar I/F Cage® (P960025) Ray TFC TM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) Technological pezoM posse… | 1996 |
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 2…2 === Predicate Devices: Lumbar I/F Cage® (P960025) Ray TFC TM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) Technological pezoM possesses the same technological characteristics as one or C… | 2008 |
| * | K082014 | Stryker Spine Avs PL Peek SpacersSummary page 2…Predicate Devices: Lumbar I/F Cage® (P960025) Ray TFC TM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) Technological pezoM possesses the same technological characteristics as one or Characteri… | 2008 |
| * | K083661 | Avs TL Peek SpacersSummary page 2…Devices: Lumbar I/F Cage® (P960025) Ray TFC TM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) Technological pezoM possesses the same technological characteristics as one or Characteristics:… | 2009 |
| * | K090166 | Avs Anterior Large Peek SpacersSummary page 2…Lumbar I/F Cage® (P960025) Ray TFC TM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) Technological pezoM possesses the same technological characteristics as one or Characteristics: mor… | 2009 |
What descends from it? (4)
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 10 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K152620 (Spine Wave, Inc., 2016) has gone furthest, with 2 descendants of its own.
- 98 other devices also cite its predicate P960025.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
pezoTM is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DOD) with up to Grade I spondylolisthesis or retrolisthesis. DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103814: Pezo Interbody Cages System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103814
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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