510(k) · Cleared
Recalled · Class III · 2025FORZA Ti Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 3, 2021 as substantially equivalent to K200052 (Orthofix, Inc., 2020) after an 86-day review. Its family tree reaches back 21 generations to 1984. 1 of the 155 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it. It has been recalled once.
- Decided
- Mar 3, 2021
- Review
- 86 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 21 generations to K841189 (1984). 148 ancestors in all. 6 later devices descend from it, 1 citing it directly. 1 of the 155 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK161129 Pillar SA PTCOrthofix, Inc. · 2016
- 2 generations backK172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR®…Orthofix, Inc. · 2017 · Recalled
- 1 generation backK200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA…Orthofix, Inc. · 2020
- This deviceK203576 FORZA Ti Spacer SystemOrthofix, Inc. · 2021
- Descendant · cites it directly · 5 of its ownK211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System…Orthofix, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK213951 FORZA XP Expandable Spacer SystemOrthofix US, LLC · 2022
- Descendant · 3 generations on · 2 of its ownK240830 Reef TO/TA System; Regatta Lateral System; Explorer TO System…Orthofix Medical, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK253420 Admiral ACP System; Explorer TO System; Laminoplasty System; Manta…SeaSpine Orthopedics Corporation · 2026
- Descendant · 4 generations on · 0 of its ownK251617 X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable…Expanding Innovations, Inc. · 2025
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 11 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 10 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 9 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 8 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 7 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 6 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 5 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 4 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 3 generations backK161129 Pillar SA PTCOrthofix, Inc. · 2016
- 2 generations backK172437 CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR®…Orthofix, Inc. · 2017 · Recalled
- 1 generation backK200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA…Orthofix, Inc. · 2020
- This deviceK203576 FORZA Ti Spacer SystemOrthofix, Inc. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 6 · See all- K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc. · 2021 · cites it directly5descendants
- K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC · 2022 · 2 generations on4descendants
- K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc. · 2024 · 3 generations on2descendants
- K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation · 2026 · 4 generations on0descendants
- K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −11 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −10 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −9 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −8 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −7 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −6 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −5 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −4 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −3 | K161129 | Pillar SA PTC | Orthofix, Inc. | 2016 | — |
| −2 | K172437 | CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC… | Orthofix, Inc. | 2017 | 3 |
| −1 | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer… | Orthofix, Inc. | 2020 | — |
| 0 (this device) | K203576 | FORZA Ti Spacer System | Orthofix, Inc. | 2021 | — |
| +1 | K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini… | Orthofix, Inc. | 2021 | — |
| +2 | K213951 | FORZA XP Expandable Spacer System | Orthofix US, LLC | 2022 | — |
| +3 | K240830 | Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C… | Orthofix Medical, Inc. | 2024 | — |
| +4 | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF… | SeaSpine Orthopedics Corporation | 2026 | — |
| +4 | K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral… | Expanding Innovations, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 14 | 0 |
| 2005 | 12 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 20 | 1 |
| 2009 | 12 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K200052 | CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer SystemSummary page 4…MAX Classifications: Class II – 21 CFR §888.3080, Intervertebral body fusion device Primary Predicate: K200052 – FORZA PTC Spacer System, SE 4/9/2020 Reason for the 510(k) Submission: Addition of 3D printed interbody devices Device Descri… | 2020 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211704 | CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer… | 2021 | 5 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2025 | Class III | Z-0895-2026 | Device Design | Labeling contains claims that are not consistently present. |
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.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 5 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 14 companies; a new generation was cleared every 11 months on median.
- 22 of the 148 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K211704 (Orthofix, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K200052.
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. 2021, 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?
The FORZA Ti Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the dise confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous…
Read the full statement (127 words)
The FORZA Ti Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the dise confirmed by patient history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved levels.
The FORZA Ti Spacer System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation system.
Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the FORZA Ti Spacer System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203576: FORZA Ti Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203576
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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